A GLOBAL ACTION FRAMEWORK FOR TB RESEARCH I N O F S U P P O R T O F W H O ’ S E N D T H E T H I R D P I L L A R T B S T R A T E G Y
WHO Librar y Cataloguing-in-Publication Data: A global action framework for TB research in suppor t of the third pillar of WHO’s end TB strategy. 1 . Tu b e r c u l o s i s - p r e v e n t i o n a n d c o n t r o l . 2 . N a t i o n a l H e a l t h P r o g r a m s . 3 . R e s e a r c h . I . Wo r l d Health Organization. I S B N 9 7 8 9 2 4 1 5 0 9 7 5 6 (NLM classification: WF 200)
2
© Wo r l d H ealt h Or ganiz at io n 2 0 15 A l l ri g h t s re s e r v ed . Pub lic a tio ns o f the Worl d Heal th Organ ization are avail abl e on th e WHO we bs i t e ( www. who . int) o r c a n b e p ur c hased f rom WHO P ress, Worl d Heal th Organ ization , 2 0 Av e n u e A p p ia , 1 2 1 1 Genev a 2 7 , Switzerl an d ( tel .: +41 22 791 3264; f ax: +41 22 79 1 4 8 5 7 ; e -m ai l : b o o kor d er s@ who . int). R e q u e s t s f o r per m issio n to r ep r od uc e o r tran sl ate WHO pu bl ication s –wh eth er f or sal e or f or n o n -c o m m e rc i a l d istr ib ution– sho uld b e addressed to WHO P ress th rou gh th e WHO website ( www. wh o . i n t/a b out/lic ensing/c o p yr igh t_f or m/en /in dex.h tml ) . Th e de s i g n at i ons em p loyed a nd the p r esen tation of th e material in th is pu bl ication do n ot i m p l y t h e e x p ressio n o f a ny op inion whatsoever on th e par t of th e Worl d Heal th Organ ization c o n c e r n i n g t h e lega l sta tus o f a ny c o untr y, territor y, city or area or of its au th orities, or c o n c e r n i n g t h e d elim ita tion of its fr ontiers or bou n daries. Dotted an d dash ed l in es on maps re p re s e n t a pp r ox im a te b o r d er lines fo r wh ich th ere may n ot yet be f u l l agreemen t. Th e m e n t i o n of sp ec ific c o m p a nies o r of cer tain man u f actu rers’ produ cts does n ot impl y th at t h ey a re e n d o rs e d o r r ec om m end ed b y the Worl d Heal th Organ ization in pref eren ce to oth ers of a s i m i l a r n a t u re tha t a r e no t m entio ned . E rrors an d omission s excepted, th e n ames of proprietar y p ro d u c t s are distinguished b y initia l c a pital l etters. A l l re as o n a bl e p r ec a utio ns ha v e b een taken by th e Worl d Heal th Organ ization to verif y th e i n f o r m a t i o n c onta ined in this p ub lic a tion . However, th e pu bl ish ed material is bein g distribu ted wi t h o u t warra nty of a ny kind , either ex p ressed or impl ied. T h e respon sibil ity f or th e in terpreta t i on a n d u s e o f t h e m a ter ia l lies with the r ea der. In n o even t sh al l th e Worl d Heal th Organ ization be l i ab l e f o r da ma ges a r ising fr o m its use. P ri n t e d b y t h e WH O D o c um ent Pr od uc tion Ser vices, G en eva, Switzerl an d W HO / HTM / T B/2 0 1 5 . 2 6
A GLOBAL ACTION FRAMEWORK FOR TB RESEARCH I N O F S U P P O R T O F W H O ’ S E N D T H E T H I R D P I L L A R T B S T R A T E G Y
A
G L O B A L
A C T I O N
F R A M E W O R K
F O R
T B
R E S E A R C H
3
PREFACE BREAKING THE TRAJECTORY OF THE TB EPIDEMIC THROUGH RESEARCH Over the last 15 years, there was remarkable progress in the fight against TB. The Millennium Development Goals (MDG) target of halting and reversing TB incidence by 2015 has been achieved and 43 million lives have been saved. This progress has been possible thanks to a number of factors, including adoption and implementation of better strategies for TB care and control in most countries world-wide, associated with economic growth in many countries, as well as advances in research which allowed the roll out of new diagnostics and drugs for t h e f i r s t t i m e i n d e c a d e s . H o w e v e r, T B i s t h e top infectious disease killer alongside with HIV/AIDS, claiming 1.5 million lives ever y year and causing suffering to millions more. As a result of the achievements in combating HIV/AIDS, tuberculosis and malaria within the context of the MDGs, the world is now turning its attention towards finishing the job and ending the three epidemics, as part of the new Sustainable Development Goals (SDG), the era of which will start o n 1 st J a n u a r y 2 0 1 6 . T h e n e w W H O E n d To r e a c h t h e s e a m b i t i o u s t a r g e t s , n e w revolutionar y technology including rapid, simple, point-of-care diagnostics for infection and disease, shorter regimens for infection and disease, and eventually an effective vaccine, are needed. This requires much invigorated efforts in research, along a continuum that links upstream fundamental research to discover y and new tool development, and ultimately to operational and implementation research allowing innovative strategic approaches to be adapted to specific countr y needs. To f a c i l i t a t e t h i s e f f o r t , t h e Wo r l d H e a l t h Organization, under the leadership of Dr Christian Lienhardt, Dr Knut Lönnroth, D r R i c h a r d M e n z i e s a n d M s D i a n a We i l , together with a wide range of experts and partner agencies, has developed this “Global Action Framework for TB Research” that sets the agenda for key stakeholders at global and national levels. The Framework describes how to strengthen TB research T B S t r a t e g y, a d o p t e d b y a l l W H O M e m b e r S t a t e s a t t h e Wo r l d H e a l t h A s s e m b l y i n M a y 2014, ser ves as a blueprint for countries to end the global TB epidemic. It sets targets to reduce TB incidence by 80% and TB deaths by 90% in 2030, and to eliminate catastrophic costs for TB-affected households by 2020.
in all countries, with special emphasis on middle-income countries carr ying the largest burden of TB, and how to support and facilitate research at global level. To a c h i e v e t h e v i s i o n o f a n i n v i g o r a t e d a n d e x p a n d e d T B r e s e a r c h g l o b a l l y, e v e r y countr y needs to ensure that the principles contained in this Framework are adopted and put into practice. In practical terms, this means, first, the development of national strategic plans for TB research based on consensus on the top priorities including capacity-building. Second, it requires the establishment of mechanisms to ensure sufficient domestic funding for TB research, that can be complemented by international f i n a n c i n g w h e n n e c e s s a r y. T h i r d , i t a l s o requires the mobilization of those public and private institutions that can contribute to research and its financing, the definitaion
of novel ways of mobilizing resources, and the expansion of national and global interactions through the establishment of networks of researchers and institutions at national and international levels. If all the principles that underpin the Framework are transformed into policies and practice in most countries world-wide, then the chances of breaking the trajector y of the TB epidemic and wiping out this ancient killer will increase exponentially over the next several years.
Dr Mario Raviglione D i r e c t o r, G l o b a l T B P r o g r a m m e Wo r l d H e a l t h O r g a n i z a t i o n
PA R T I Strengthening TB research in low- and middle-income countries most affected by TB
20
P A R T II Supporting and facilitating research at global level
44
P A R T III The role of WHO
54
REFERENCES ANNEX 1 ANNEX 2
61 62 70
A
INTRODUCTION
12
G L O B A L
SUMMARY
10
A C T I O N
ACKNOWLEDGEMENTS
8
F R A M E W O R K
F O R
T B
R E S E A R C H
TA B L E O F CONTENTS
7
ACKNOWLEDGEMENTS The authors are extremely grateful to the participants of the Global Consultation on Research for TB Elimination that has established the basis for the present d o c u m e n t , a n d a r e l i s t e d t h e r e - u n d e r. T h e y acknowledge with gratitude the many persons who contributed to the development of the document. Overall coordination Christian Lienhardt, Dick Menzies. Core writing team Christian Lienhardt, Dick Menzies, Knut L ö n n r o t h , D i a n a We i l . Contributors and peer-reviewers I b r a h i m A b u b a k a r, H a n n a h A k u f f o , S t e f a n o Aliberti, Manica Balasegaram, Anurag Bhargava, Delia Boccia, Erlina Burhan, Joseph Cavanaugh, Richard Chaisson, Muhwa Jeremiah Chakaya, Gavin Churchyard, Isabelle Cieren- Puiseux, Daniela Maria Cirillo, Frank Cobelens, Martin Colla, Liz Corbett, Colleen Daniels, P a t r i c e D e b r é , To m E v a n s , S a r a E y a n g o h , Alberto Garcia-Basteiro, Willem Hanekom, Anthony D. Harries, Norbert Heinrich, M i c h a e l H o e l s c h e r, S v e n H o f f n e r, C . Robert Horsburgh, Gunilla Källenius, Nadia Khelef, Gilla Kaplan, Alison K r a i g s l e y, A f r a n i o K r i t s k i , A j a y M . V. K u m a r, Global TB Programme: Hannah Monica Dias, Dominique De Santis, Ernesto Jaramillo, Christian Lienhardt, K n u t L ön n roth , Al ber to Matteel l i ( n ow at Health Service Research: A b d u l G h a f f a r. WHO Regional Offices: Karam Shah, EMRO; Colleen Acosta, EURO; Mirtha del Granado, AMRO.
8
Christoph Lange, José Roberto Lapa e Silva, David Lewinsohn, Davide Manissero, Harriet M a y a n j a - K i z z a , R u t h M c N e r n e y, C h a r l e s S . M g o n e , Va l e r i e M i z r a h i , Ya - D i u l M u k a d i , Payam Nahid, James Nicholas Newell, Viet N h u n g N g u y e n , A n d e r s N o r d s t r ö m , To m H.M. Ottenhoff, Roxana Rustomjee, Andreas S a n d g r e n , T h o m a s S h i n n i c k , C h r i s t i n e F. Sizemore, Melvin K. Spigelman, S. Bertel Squire, Beena Thomas, Rony Zachariah, Alimuddin Zumla. Contributors to case-studies: Afranio Kritski, Andargachew Kumsa, Jeremiah Chakaya, R o b e r t o L a p a , A n d r e w R a m s a y, R o x a n a Rustomjee, Sudha Srinivasan.
W O R L D H E A LT H O R G A N I Z AT I O N :
U p l e k a r, D i ana Weil. Special Programme for Research and Tr a i n i n g i n Tr o p i c a l D i s e a s e s ( T D R ) : C o r i n n e M e r l e , R o b Te r r y. Overall guidance was provided by the Director of the Global TB Programme, Mario Raviglione. Administrative and secretarial support: Janet Coutin, Jasmine Solangon.
to the Global Consultation on TB Research i n S t o c k h o l m o n 2 4 - 2 5 th N o v e m b e r 2 0 1 4 i s greatly acknowledged. The Bill and Melinda Gates Foundation is acknowledged for its support to the development of this document through grant project number OPP1131404. The co-authors, and the institutions where they work, contributed their time to the drafting of chapters, follow-up editing, and review of the final document; this support is also gratefully acknowledged.
A
G L O B A L
A C T I O N
F R A M E W O R K
M c G i l l U n i v e r sity), Ma r io R a v iglione, Mu k u n d
Foreign Affairs and the Karolinska Institutet
F O R
( o n s a bb at i c a l fr om Montr ea l Chest Institu te,
The support from the Swedish Ministr y of
T B
U n i v e rs i t y o f B r esc ia , Ita ly), D ic k Menzies
Funding:
R E S E A R C H
9
SUMMARY T h e Wo r l d H e a l t h O r g a n i z a t i o n ’s ( W H O ) End TB Strategy aims to end the global tuberculosis (TB) epidemic by 2035. It t a r g e t s a 9 5 % r e d u c t i o n i n T B m o r t a l i t y, a 90% decline in TB incidence (to below 10/100,000 population) and zero catastrophic costs for TB-affected h o u s e h o l d s . To r e a c h t h e s e a m b i t i o u s t a r g e t s , intensified research is needed to develop more effective inter ventions to detect, cure and prevent TB. This constitutes the third p i l l a r o f t h e E n d T B S t r a t e g y, ‘ I n t e n s i f i e d research and innovation’. It highlights the need for global research at all levels along the research spectrum (from basic science to operational research), as well the need to empower a strong and self-sustained TB research community in low- and middle income countries with high TB burden. To a s s i s t w i t h t h i s , W H O , w i t h c o n t r i b u t i o n s from many stakeholders, has developed a Global Action Framework for TB Research to foster high-quality national and global TB research over the next 10 years to 2025. The first part of the framework describes how to strengthen TB research in low- and middle-income countries most affected by TB by developing a national TB research plan. Key steps include the development or reinforcement of the following: (i) a national TB research network; (ii) a countr yspecific TB research agenda based on the The third part of the framework describes W H O ’s a c t i v i t i e s i n s u p p o r t o f t h e The second part of the framework describes how to enhance TB research globally by applying efforts to building strong research partnerships and networks and securing robust funding for research. Key steps include (i) mobilising more funding resources at global and national levels; (ii) holding regular TB research donors’ forum; (iii) developing innovative funding mechanisms; (iv) expanding advocacy activities to increase TB research funding internationally; (v) creating international networks and thematic hubs to enhance collaboration on TB research; and (vi) undertaking larges c a l e , c r o s s - c u t t i n g , m u l t i - d i s c i p l i n a r y, m u l t i site, collaborative research projects.
1 0
characteristics of the TB epidemic and an inventor y of resources and activities; (iii) a plan for training and sustained capacity building on TB research; (iv) sustained national TB research funding mechanisms for training, infrastructure and research operations; (v) advocacy for public support and funding of TB research; and (vi) ongoing monitoring and evaluation of the implementation of the framework. A checklist is provided to guide countries in assessing their research capacity and preparedness prior to developing a national TB research plan.
to countries implementing Pillar 3 of the E n d T B S t r a t e g y, a s w e l l a s w o r k w i t h international, bilateral and national stakeholders to foster TB research. A WHO A series of milestones and deliverables are provided for the coming 1, 5 and 10 years for these activities.
© WHO/SEARO/David Orr
A
G L O B A L
A C T I O N
F R A M E W O R K
documents to provide technical assistance
the Global Action Framework.
F O R
development of guidance tools and
guide this work and assist in implementing
T B
framework. These activities include the
Ta s k F o r c e o n G l o b a l T B R e s e a r c h w i l l
R E S E A R C H
1 1
INTRODUCTION T h e E n d T B S t r a t e g y a p p r o v e d b y t h e Wo r l d Health Assembly in May 2014 aims to end the global tuberculosis (TB) epidemic by 2035 (1). It targets a 95% reduction in TB m o r t a l i t y, a 9 0 % d e c l i n e i n T B i n c i d e n c e and zero catastrophic costs for TB-affected households. The strategy (Figure 1) relies on three fundamental pillars: • PILLAR 1: Integrated, patient centred care and prevention • PILLAR 2: Bold policies and supportive systems •
1 2
of a global research effort along the entire research spectrum from basic science to operational research (Box 1). Basic research will help elucidate fundamental mechanisms in the pathogenesis of tuberculosis as a first step in the discover y of new control tools: rapid and sensitive point-of-care diagnostic tests; short, effective and safe regimens for the treatment of drugsensitive and resistant TB disease and latent TB infection; and an effective vaccine or other preventive inter ventions. Clinical and t r a n s l a t i o n a l r e s e a r c h w i l l e valuate safety an d ef f icacy of th ese n ew diagn ostic, treatmen t an d preven tive tool s. Epidemiol ogic resea r ch wil l provide a more compl ete u n derstan ding of th e deter min an ts an d con sequ en ces of TB an d of th e n atu ral cou rse of in f ection an d disease. En h an ced su r veil l an ce is rel atively simpl e an d in expen sive an d wil l con tribu te t o u n derstan din g th e epidemiol ogic situ ation i n each cou n tr y, as wel l as f acil ita t e o p e r a t i o n a l and implementation research. Behavioural, operational and implementation research will help identify setting-specific barriers to access care and to adherence, to encourage the use of new diagnostic and treatment tools, and to determine locally appropriate innovative policies and approaches for TB p r e v e n t i o n a n d c a r e . F i n a l l y, h e a l t h s y s t e m s and social science research provide an understanding of fundamental elements of health and social ser vice functioning, f i n a n c i n g a n d d e l i v e r y.
PILLAR 3: Intensified research and innovation
Despite recent advances in the of new TB diagnostics and anti-TB drugs, overall progress in reducing TB incidence and related deaths, burden and costs in the most affected communities is limited by inadequate tools to detect, treat or prevent TB. This inadequacy is compounded by weaknesses in health systems and associated social determinants. To r e a c h t h e a m b i t i o u s t a r g e t s s e t b y t h e W H O E n d T B S t r a t e g y, i n t e n s i f i e d r e s e a r c h is needed into better inter ventions to detect, cure and prevent TB. This should be part
F I G U R E 1 / W H O E N D T B S T R AT E G Y
PILLAR 1 Integrated, patient-centered TB care and prevention
FOUR PRINCIPLES
Building a strong coalition with civil society and communities Protecting and promoting human rights, ethics and equity Adaptation of the strategy and targets at countr y level, with global collaboration
D i s c o v e r y, d e v e l o p m e n t a n d r a p i d uptake of new tools, inter ventions and strategies.
Research to optimize implementation and impact; and promote innovations.
A
G o v e r n m e n t s t e w a r d s h i p a n d a c c o u n t a b i l i t y, w i t h m o n i t o r i n g a n d e v a l u a t i o n
G L O B A L
A C T I O N
F R A M E W O R K
Bold policies and supportive systems
Intensified research and innovation
F O R
PILLAR 2
PILLAR 3
T B
R E S E A R C H
1 3
1 4
BOX 1/THE SPECTRUM OF RESEARCH Basic/fundamental research: investigation of the characteristics of the germ and analysis of the host-pathogen interaction to decipher the basic mechanisms of transmission, infection, latency and disease, including response to therapy and to vaccination. This includes disciplines such as molecular b i o l o g y, i m m u n o l o g y a n d b i o c h e m i s t r y. Operational and implementation research: research into strategies, inter ventions, tools or knowledge which can improve programme per formance and/or health care deliver y. It is generally the simplest, quickest and least costly research methodology. This research examines the conditions, requirements and barriers to implementation, as well as inter ventions to enhance the use of new or existing Clinical and translational research: a s s e s s m e n t o f t h e s a f e t y, e f f i c a c y and validity of new inter ventions or approaches (algorithms) in patient populations. This includes research on new diagnostics, new drugs or regimens and vaccines (Phase 1 to 3 randomized trials). tools and strategies by patients and health systems. It also contributes to documenting the safety profile of new inter ventions (drug, regimens, vaccines) during routine use in large populations. To be successful, this type of research requires identifying clear questions that are amenable to study, have a direct impact on major policy and implementation issues, and can be answered by low-cost research methods.
F U N D A M E N TA L SCIENCE
T R A N S L AT I O N A L STUDIES
PRECLINICAL STUDIES
Epidemiologic research: examination of the natural course of TB infection and disease and the various determinants and consequences of TB. This includes analysis of sur veillance and population-level data (such as prevalence sur veys or drug resistance sur veys), as well as personal, medical and social determinants of TB transmission, infection, progression to active disease, drug resistance, and disease outcomes. This also includes studies to estimate the socioeconomic consequences of TB for the individual, h o u s e h o l d s a n d s o c i e t y.
P o l i c y, h e a l t h a n d social system research: investigation of the interplay of social, population and personal factors that affect health-seeking behaviours, and wider health systems organization and dynamics. This research also investigates the effectiveness of policy and regulatory interventions on TB prevention and care, particularly the means to ensure universal health coverage, through social protection and actions on the social determinants of health.
CLINICAL STUDIES/TRIALS
DEPLOYMENT AND SCALE UP I M P L E M E N TAT I O N / O P E R AT I O N A L R E S E A R C H
A
G L O B A L
A C T I O N
F R A M E W O R K
F O R
T B
R E S E A R C H
1 5
1 6
Clearly the need to expand TB research and innovation worldwide is urgent and requires the creation of researchenabling environments where the TB burden is greatest: in low- and middleincome countries. Over the next decade, it is expected that these countries will progressively establish their leadership in TB research by strengthening their own research capacity through domestic funding. This strengthened capacity will not only h e l p a c h i e v e t h e E n d T B S t r a t e g y ’s g o a l s b u t will contribute to global research efforts to eliminate TB (Figure 2). In parallel, highincome countries, international agencies and philanthropic organisations are also expected to increase their investments in TB research and training. The challenge of the next decade will be twofold. First, the next generation of
scientists in high-burden countries will h a v e t o be train ed an d equ ipped to f in d sol u tion s to en din g T B both in th eir cou n tri es an d gl obal l y. Secon d, research resu l ts wil l requ ire wider dissemin ation , especial l y to pol icy-makers, en su rin g th ese resu l ts are actu al l y u sed an d th at in vestmen t in resear ch con tin u es. T h e G l obal Action Framework f or T B Resea r ch was devel oped by WHO in col l aboration with a broad ran ge of stak eh ol ders to f ost er h igh -qu al ity T B research , both n ation al l y an d gl obal l y, f or th e n ext 10 years ( 20162025) . T h e f ramework bu il ds on th e ou tco mes of a G l obal con su l tation on research f or TB el imin ation organ ized in Stockh ol m by th e WHO G l obal T B P rogramme, th e Swedish G over n men t an d th e Karol in sk a In st i t u t e t in November 2014, that proposed the following 10-year vision for TB research.
F I G U R E 2 / P R O J E C T E D A C C E L E R AT I O N O F T B I N C I D E N C E D E C L I N E T O TA R G E T L E V E L S
Rate per 100,000/year
100 Optimize use of current & new tools emerging from pipeline, pursue universal health coverage and social protection
Current global trend: -1.5%/year
50
-10%/year by 2025 Introduce new tools: a vaccine, new drugs and shorter regimens for treatment of active TB and latent infection, a point-of-care test
-5%/year
-17%/year 2030 2035
0 2015 2020 2025 Ye a r
© WHO/TDR/Simon Lim
A
G L O B A L
A C T I O N
F R A M E W O R K
F O R
T B
R E S E A R C H
1 7
1 8
THE 10-YEAR VISION To a c h i e v e t h e t a r g e t s s e t b y t h e W H O E n d T B S t r a t e g y f o r 2 0 3 0 / 2 0 3 5 , t h e r e i s a need for intensified research to deliver new tools and strategies to combat the disease, including rapid and sensitive point-of-care diagnostic tests, short regimens for the treatment of TB disease and latent TB infection, and an effective vaccine. These novel tools, as well as any innovation, must be linked with relevant epidemiological, health systems, and operational research to ensure their adoption and implementation to scale. To a c h i e v e t h i s v i s i o n i t i s e s s e n t i a l t h a t , o v e r t h e n e x t d e c a d e , c o u n t r i e s w i t h s u b s t a n t i a l TB burden progressively establish their leadership for TB research by ensuring the necessar y funding through domestic public investments (especially in the middle-income high burden countries, including the BRICS) and by building strong domestic capacity with the necessar y international collaboration within the larger context of health research. It is also crucial that high-income countries and their institutions enhance their engagement and investments in TB research overall, including multidisciplinar y TB research, to address specific barriers impeding TB elimination, and that they collaborate with, and support, institutions in high-incidence countries. This vision also relies on ongoing global commitment to addressing health as a development priority and to research and innovation across the globe.
The Global Action Framework for TB Research has been designed to help achieve this 10-year vision, with two fundamental objectives:
It sets the principles for action on TB research and recommends the roles, responsibilities and deliverables for major stakeholders, both global and national. It is designed for use by a wide range of groups and individuals including ministries of health and their national TB programmes, ministries of science and technology, national research institutes, academia, researchers, international and national donors and technical agencies, NGOs and civil society. The Framework is composed of three par ts: Par t I: Strengthening TB research in low and middleincome countries most af fected by TB Par t II: Suppor ting and facilitating research at global level Par t III: The role of WHO
To p r o m o t e , e n h a n c e a n d i n t e n s i f y TB research and innovation at countr y level, with a focus on 1 low- and middle-income countries, through the development of countr yspecific TB research plans and s t r o n g r e s e a r c h c a p a c i t y.
To p r o m o t e , e n h a n c e a n d c a t a l y s e TB research at global level through a d v o c a c y, s h a r i n g i n n o v a t i o n s , 2 discussion of global priorities in TB research and development of regional and international networks for research and capacity building.
GLOBAL ACTION FRAMEWORK M I L E S T O N E S A N D D E L I V E R A B L E S AT A G L A N C E
2020
2025
Countries
•
Established a national TB research network; Integrated TB research within the National TB Strategic Plan; Developed a list of national TB research priorities; Initiated in-countr y research training.
•
Developed and implemented a national TB research plan; Established sustained mechanisms for national TB research funding; Created a strong TB research capacity; Empowered a strong and self-sustained TB r e s e a r c h c o m m u n i t y.
•
•
•
• •
•
Global
It is expected that: • At least three new crossnational TB research networks will be established; At least three large multicentre and cross-cutting collaborative studies will be initiated; At least two new innovative financing mechanisms will be implemented; Full funding of TB research will be ensured at least in the BRICS countries.
It is expected that: • High-income countries will have enhanced their commitment and investments in Research and Development (R&D) for TB; Mechanisms will be in place for global networking on TB R&D; Novel funding mechanisms will be implemented to enhance TB R&D; At least five large scale, multicentre, crosscutting collaborative research projects will be conducted.
•
•
•
•
•
•
WHO
WHO will have: • Wo r k e d w i t h a t l e a s t t h r e e model countries to develop and implement a national TB research plan; Organized a multi-countr y meeting on lessons learned from model countries; Published an updated version of the Global Action Framework for TB Research; Published TB research investment case studies; Included progress in TB R&D at countr y level within the WHO Global TB Report.
WHO will have: • Assisted high TB burden countries to develop and implement a national TB research plan; Wo r k e d w i t h c o u n t r i e s a n d d o n o r s a t national and international levels to expand the funding base for TB research along the continuum; Assisted countries to create a strong TB research capacity; Supported the creation of regional hubs and international networks for TB research; Included progress in TB R&D at countr y level within the WHO Global TB Report.
•
•
•
•
•
•
•
•
A
G L O B A L
A C T I O N
F R A M E W O R K
All countries with high TB burden will have:
All countries with high TB burden will have:
F O R
T B
R E S E A R C H
1 9
2 0
PA R T I
R E S E A R C H A N D C O U N T R I E S A F F E C T E D
I N
L O W -
B Y
T B
THIS CHAPTER DESCRIBES HOW TO STRENGTHEN TB RESEARCH IN LOW- AND MIDDLE-INCOME COUNTRIES MOST AFFECTED BY TB T H R O U G H T H E D E V E L O P M E N T O F A N AT I O N A L T B R E S E A R C H P L A N .
The six key steps in developing and implementing the national TB research plan are described in detail: 1. Develop (or reinforce) a national TB research network; 2. Develop a countr y-specific TB research plan based on the characteristics of the TB epidemic and an inventor y of resources and activities; 3. Develop a plan for sustained capacity building on TB research;
4. Establish sustained national TB research funding for training, infrastructure and research operations; 5. Advocate for public support and funding of TB research; and 6. Undertake monitoring and evaluation of the implementation of the framework. A checklist is provided to guide countries in assessing their research capacity and preparedness prior to developing a national TB research plan.
A
G L O B A L
A C T I O N
F R A M E W O R K
M O S T
F O R
M I D D L E - I N C O M E
T B
R E S E A R C H
S T R E N G T H E N I N G
T B
2 1
2 2
To s u b s t a n t i a l l y e x p a n d T B - r e l a t e d research, each country should develop a comprehensive national TB research plan integrated within the National TB Strategic Plan (NSP) to promote and catalyse TB research in the country over the next 10 years.
The plan should identify research considered essential to achieving the 2030/2035 E n d T B S t r a t e g y t a r g e t s . E a c h c o u n t r y ’s financing and pace of implementation will v a r y, d e p e n d i n g o n i t s c u r r e n t T B b u r d e n , r e s e a r c h c a p a c i t y, a n d p o l i t i c a l a n d financial support. The plan is expected to
FIGURE 4/KEY STEPS IN DEVELOPING AND I M P L E M E N T I N G A N AT I O N A L T B R E S E A R C H P L A N
STEP 1
STEP 2
STEP 3
Develop countr y-specific TB research priorities Establish mechanisms for collaboration between all stakeholders at national and international levels: the development of a national TB research network. based on the current TB epidemic, an assessment of the national health system and research c a p a c i t y, a n d a n understanding of what is needed to achieve the WHO End TB Strategy targets by 2030/2035. Plan for relevant training and sustainable capacity building, including researchers and research careers development from an early stage.
2020 and in all countries by 2025. A few countries already have substantial TB research capacity and may be able to develop and implement a national TB r e s e a r c h p l a n r a p i d l y. T h e s e c o u n t r i e s w i l l
ser ve as ‘path-finding’, or model, countries for TB research. Figure 3 below summarizes research plan and the potential activities, roles and responsibilities of different stakeholders. R E S E A R C H A G L O B A L A C T I O N F R A M E W O R K F O R T B
proposed key steps for a national TB
STEP 4
STEP 5
STEP 6
Advocate for public Ensure adequate funding is provided for training, infrastructure and research operations. support and funding of TB research. This step must be initiated early and continued throughout all phases of the plan.
Establish mechanisms, milestones and indicators for ongoing monitoring and evaluation of the implementation of the TB research plan.
2 3
be fully implemented in many countries by
achieve milestones more quickly and will
KEY STEPS IN DEVELOPING AND IMPLEMENTING A NATIONAL TB RESEARCH PLAN 1 / E S TA B L I S H MECHANISMS FOR C O L L A B O R AT I O N BETWEEN ALL S TA K E H O L D E R S AT N AT I O N A L L E V E L : THE DEVELOPMENT O F A N AT I O N A L T B RESEARCH NETWORK To m ak e be s t use of a c o untr y’s lim ited h u m an , ph y s i ca l a nd fina nc ia l r eso ur c es, T Bre l at e d re s e a rc h should b e c oor d ina ted with re s e a rc h e rs i n a ll d isc ip lines a nd the Nation al TB P ro g ram m e (NTP) c olla b or a ting c lo sel y. Establishing or strengthening an existing national TB research network is an important early step towards a national TB research plan. The network should be seen as a partnership between public and non-government sectors in which health practitioners and researchers from government agencies, particularly the NTPa of the Ministr y of Health (MoH), should collaborate closely with TB researchers from
2 4
various disciplines at national universities, research institutions, and associations. Where possible, collaboration should extend to other government agencies or ministries, such as the Ministr y of Science a n d Te c h n o l o g y ( M o S T ) . A truly effective network also requires the participation of research beneficiaries, including community and civil society representatives. Ever y effort should be made to include representatives from Non Governmental Organizations (NGOs) and t h e p r i v a t e s e c t o r, i n c l u d i n g p r o f e s s i o n a l a s s o c i a t i o n s , p r a c t i t i o n e r s a n d i n d u s t r y. The network should be as inclusive and multi-disciplinar y as possible, for example involving researchers and institutions not currently doing TB research but addressing cross-cutting related research questions. International research expertise would also be helpful, including from WHO, international NGOs or universities in highincome countries. The network should be able to help in the inventor y and in the formulation of the national TB research agenda, including n ational research priorities (see below). Box 2 gives an example of a TB research network in Brazil (2).
a
It is suggested that each NTP designates a TB research focal point, ideally with a background in research. Domestic research institutions would similarly designate one of their researchers (ideally with a clinical or public health background) to be the TB focal point so as to encourage ongoing dialogue and exchange.
Before 2001, Brazil had substantial research capacity but ver y little cooperation and no coordination between industry, universities, the various research institutes, health services and the NTP. In 2001 the Ministry of Science and Technology launched a call for applications to promote the creation of research networks in all areas. The TB network was created and funded, entitled REDE-TB . REDE-TB is a multi/interdisciplinary group of researchers and students from health sciences, engineering and education, with civil society partners and health service representatives from all levels of TB and AIDS programmes (federal, state and municipal). The main objective of REDE-TB is to promote research and educational activities in an integrated manner to contribute to TB and TB/HIV control. REDE-TB researchers were invited by the Ministry of Science and Technology and the Ministry of Health to help define a national TB research agenda in 2004, 2007 and 2010. Research topics were identified by REDE-TB researchers, TB and AIDS Programme coordinators, representatives from the Oswaldo Cruz Foundation (Fiocruz) and civil society. In 2004, REDE-TB initiated a project for research training with US National Institutes of Health (NIH) funding. The creation of REDE-TB helped build bridges between university-based researchers, the public health system (and particularly the NTP), industry and civil society. The university-based researchers helped produce scientific knowledge that responds to local demands, through operational and health system research approaches. The network helped the NTP by conducting studies of strategic importance to the NTP, and through expert guidance committees on specific technical issues (such as diagnosis and treatment of latent TB infection (LTBI)). (REDE-TB - www.redetb.org.br)
The network should undertake broad o u t r e a c h . In i t ia lly, r esea r c her s a nd instit u tion s c an b e l i m i t e d , b ut the netwo r k should s oon r e a c h o u t a n d c o nnec t with other sta kehol ders n a t i o n al l y, a s well a s d o nor s a nd gr o up s f ro m o t h e r c o untr ies inv olv ed in c olla b orative r e s e a rc h ac t i v ities. This sho uld help c r eate r e g i o n al n e t w o r ks a nd foster r egio na l p roj e c t s i n T B r e s e a r c h . F i n a l l y, t h e n e t w o r k c o u l d also participate in international TB research networks addressing specific research themes.
2/DEVELOP C O U N T R Y- S P E C I F I C N AT I O N A L T B RESEARCH PRIORITIES A key component of the TB research p l a n i s a p r i o r i t i z e d l i s t o f a c o u n t r y ’s most important research questions. These priorities should be based on a thorough understanding of the current TB epidemic, the research most needed to achieve the
A
G L O B A L
A C T I O N
F R A M E W O R K
F O R
T B
BOX 2/MULTI-DISCIPLINARY AND M U LT I - C E N T R E N AT I O N A L T B R E S E A R C H NETWORKS – THE EXAMPLE OF THE BRAZILIAN TB RESEARCH NETWORK
R E S E A R C H
2 5
2 6
End TB targets, and an inventor y of existing TB research capacity at countr y level. The list should be developed by members of the network with and within broader national health research strategies. Inevitably the timing and intensity of this process will var y s u b s t a n t i a l l y b y c o u n t r y. The steps needed to develop these priorities a r e o u t l i n e d b e l o w.
gener al l y available at national level, as well as submitted by national sources to the WHO for its Global TB Report (3) and presented in individual TB countr y profiles which are part of WHO’s global TB database b . Available data on subnational geographical distribution, particular situations (such as transmission ‘hot spots’) or vulnerable groups (e.g. migrants, refugees, prisoners, indigenous populations) should also be reviewed. Finally, data from national or subnational prevalence or drug resistance sur veys and sur veys on TB/HIV co-infection, as
2 . 1 I N I T I A L S I T U AT I O N ASSESSMENT A baseline assessment of the TB epidemic a n d o f a c o u n t r y ’s T B r e s e a r c h c a p a c i t y is highly recommended to establish the basis upon which activities to promote and enhance TB research will be built and identify potential bottlenecks and opportunities to address them. This assessment is a major requirement within the overall End TB Strategy and can be undertaken by using a checklist developed for this purpose (see Annex 1).
well as other determinants of the TB epidemic (smoking, malnutrition, diabetes etc.) can provide important additional information (4).
2.1.2 THE BROADER HEALTH CONTEXT Information on the structure and financing of the national health system and national health research should be reviewed, along with strengths and weaknesses. This process could be strengthened by applying lessons learned from research and priority setting in other health or disease research areas. (Note: good practices in priority setting are r e v i e w e d i n t h e W H O Wo r l d H e a l t h R e p o r t 2013) (5,6,7)
2.1.1 DESCRIPTION OF THE CHARACTERISTICS OF THE TB E P I D E M I C AT C O U N T RY L E V E L Th i s de s c ri p t i on sho uld b e b a sed o n the f o l l o wi n g f a c tor s: estim a ted inc id enc e, p re v al e n c e , c a se d etec tio n a nd m or ta lity, an d TB c a s e n o t i f ic a tio n a nd tr ea tm ent o utc omes b y t yp e o f TB (d r ug-susc ep tib le, MD R -TB, TB/ H IV ) an d age/sex . These d a ta a r e
2.1.3 THE INVENTORY OF TB R E S E A R C H C A PA C I T Y An inventor y of the existing capacity for TB research (in terms of human resources, physical
b
S e e : h t t p : / / w w w. w h o . i n t / t b / c o u n t r y / d a t a / p r o f i l e s / e n /
carried out and include the following areas: (i) Mapping the institutions involved in TB-related research and their productivity The inventor y would include key government agencies, public or private research entities a n d N G O s i n t h e c o u n t r y, i n t e r n a t i o n a l bodies with substantial involvement in the c o u n t r y, i n s t i t u t i o n s c o n d u c t i n g r e s e a r c h o n cross-cutting themes relevant for TB and, m o r e s p e c i f i c a l l y, t h e N T P ’s e n g a g e m e n t in research. The inventor y should describe physical infrastructure and equipment and available human resources (including details about type of training/positions). Ideally the inventor y would cover the strengths and challenges of the different institutions and their recent TB-related publications. (ii) TB-related research training Available or planned training courses should be listed, including the training institutions, disciplines and types of training available (fundamental, epidemiologic, clinical, l a b o r a t o r y, h e a l t h s y s t e m , s o c i a l s c i e n c e s , or operational research), level of training ( u n d e r g r a d u a t e , M a s t e r ’s , P h D , o r P o s t - D o c ) , and funding to support trainees. Links with international training courses should be mentioned. (iii) TB-related research funding National sources of funding should be identified, whether from public (national, provincial or state governments) or private s o u r c e s ( i n d u s t r y, p h i l a n t h r o p i c i n s t i t u t i o n s ,
international agencies, bilateral agencies, industr y or philanthropic donors should partnerships with international investigators (for example from multi-centre studies). (iv) Research ethics Capacity should exist within the countr y f o r a t i m e l y, m u l t i - d i s c i p l i n a r y a n d knowledgeable research ethics review to ensure rapid approvals for research projects, as appropriate. A thorough inventor y can be time-consuming, h o w e v e r, a n d r e q u i r e f r e q u e n t u p d a t e s . F o r t h i s r e a s o n , t h e i n v e n t o r y ’s r a t i o n a l e , objectives, planned use and level of detail should be agreed by all stakeholders beforehand. R E S E A R C H A G L O B A L A C T I O N F R A M E W O R K F O R T B
also be mentioned, as well as potential
2.2 DEVELOPMENT OF TB RESEARCH PRIORITIES On the basis of the above activities, a list of countr y-specific TB research priorities will be developed by the TB Research Network (described above), (see Boxes 3 and 4 for examples from Ethiopia and Kenya). This prioritized list of research questions should be those viewed as essential to address the national as well as the global TB epidemic. The development of these priorities should respect three key principles:
2 7
infrastructure and operations) should be
NGOs). External sources, such as
2 8
BOX 3/ USING THE NATIONAL TB RESEARCH NETWORK IN A LOW INCOME COUNTRY AS A KEY PART OF THE NATIONAL RESEARCH PLAN: THE TUBERCULOSIS RESEARCH ADVISORY COMMITTEE (TRAC) IN ETHIOPIA Background: In 2001, the TB and Leprosy Control Team (TLCT) of the Federal Ministr y of Health organized a landmark TB Research Workshop (with suppor t from TDR/WHO and the Ethiopian Science and Technology Commission) during which TRAC was appointed to conduct research within the countr y, based on national priorities and needs. TRAC is a voluntar y network of NTP and other relevant MOH depar tments, public research institutions, major national universities, professional associations and other key TB stakeholders. It is a core technical advisor y body to the NTP that sets TB research priorities and builds national capacity to conduct TB research. Over the last 14 years TRAC has been actively engaged in the promotion, conduct and dissemination of operational research in TB control and has been a forum for dialogue and interaction between researchers and NTP staf f in Ethiopia. The NTP acts as the Secretariat for TRAC, while the chairperson rotates each year among member institutions. Objectives: 1) Define national TB research priorities; 2) Create a conducive environment for TB research; 3) Review current status and problems of operational and other forms of TB research in the countr y; 4) Recommend ef fective and ef ficient mechanisms for coordination, management, and evaluation of TB research, as well as dissemination and uptake of results; 5) Identify potential TB research funding institutions or organisations; 6) Identify needs for capacity building to facilitate TB research in Ethiopia; 7) Promote TB research and innovation at all levels of the health system. Activities: TRAC has organized annual research conferences for the past 10 years during which the number of par ticipants and papers presented has significantly increased. Consultations and side meetings are held on selected thematic areas of national implication for programmatic design and scale-up of ser vices and a list of priority research projects are discussed and endorsed by all conference par ticipants. To date, TRAC has organized 12 rounds of operational research methodology training for 240 exper ts working at all levels of the health system from across the countr y. TRAC has also provided operational research training courses and developed an operational research grant mechanism to provide funding for researchers from public institutes and universities and health care deliver y systems working collaboratively. As par t of ongoing monitoring and evaluation, TRAC, in collaboration with the NTP, has initiated mapping and review of TB operational research activities and publications in Ethiopia.
needs and capacity; (2) they should include the full continuum of research – from fundamental to operational that is being or could be conducted in that countr y; and, ( 3 ) t h e y s h o u l d c a p ita lize o n c ountr ies assets. The actors most involved in setting priorities m a y v a r y d e p e n d i n g o n a c o u n t r y ’s c a p a c i t y for different types of research: •
research as well as drug, diagnostic or vaccine development are more likely to research capacity and funding options, as well as the global TB research agenda (9). For this type of prioritysetting, the Ministr y of Science and Te c h n o l o g y, t h e c o u n t r y ’s a c a d e m i c institutions and national industr y will likely be involved, whereas the involvement of the NTP might not be essential. The list of priorities should also be realistic. Rather than a long ‘shopping list’ which r e p r e s e n t s t h e i n t e r e s t s o f e a c h s t a k e h o l d e r, only a few priorities should be selected to ensure efforts and resources are tightly focused. This will enhance the likelihood of success. Priorities should be established for the next five years and a process put in place for periodic review and revision of the agenda. R E S E A R C H A G L O B A L A C T I O N F R A M E W O R K F O R T B
b e b a s e d o n t h e p o t e n t i a l o f a c o u n t r y ’s
Clinical (translational), epidemiologic, implementation and operational research usually attempt to address a c o u n t r y ’s n e e d f o r d a t a t o g u i d e i t s T B control inter ventions and evaluate their impact. Identification of countr y-specific research priorities that fit within these types should be made collaboratively by the National TB programme, other public health representatives and academic stakeholders (8).
2 9
( 1 ) t h e y s h o u l d b e t a i l o r e d t o t h e c o u n t r y ’s
•
C o n v e r s e l y, p r i o r i t i e s f o r f u n d a m e n t a l
3 0
B O X 4 / S E T T I N G A N AT I O N A L T B R E S E A R C H S T R A T E G Y I N K E N YA TB remains a major public health concern in Kenya. In 2013 Kenya notified close to 100,000 cases of TB (about 250 TB cases/100,000 population). Although Kenya has made tremendous progress in its war against TB, many challenges remain, including: inability to detect all incident cases of TB, delays in TB diagnosis, inadequate uptake of inter ventions to rapidly identify and prevent TB in persons l i v i n g w i t h H I V, p r e v e n t i o n , c a r e a n d c o n t r o l o f d r u g - r e s i s t a n t T B a n d s y s t e m a t i c screening of vulnerable groups for TB. The solutions for many of these challenges will only come from programme-based operational research to identify the most a f f o r d a b l e , s u s t a i n a b l e , e f f e c t i v e a n d e f f i c i e n t a p p r o a c h e s . To a c h i e v e t h i s , K e n y a formed a multi-stakeholder national TB research task force in 2008 which was charged with several responsibilities including to: •
I d e n t i f y t h e T B p r o g r a m m e ’s r e s e a r c h p r i o r i t i e s , a n d d e v e l o p a s t r a t e g i c p l a n f o r multi-year operations research;
•
Guide and support the development and review of research proposals; Organize forums for dissemination of research findings to all stakeholders and the integration of research findings into routine programme activities;
•
•
Design and evaluate training programmes for operations research; Maintain an inventor y of planned, ongoing and completed TB research projects; Mobilize resources for TB and TB/HIV research, and coordinate all TB and TB/ HIV research activities to ensure conformity with identified national research priorities;
•
•
•
Develop guidelines and ethical standards for TB and TB/HIV research.
T h e t a s k f o r c e o r g a n i z e d a w o r k s h o p i n O c t o b e r 2 0 0 8 i n w h i c h K e n y a ’s T B r e s e a r c h priorities were identified. These research priorities were updated at a second workshop in March 2013.
© WHO/TDR
A
G L O B A L
A C T I O N
F R A M E W O R K
F O R
T B
R E S E A R C H
3 1
3/PLAN FOR RESEARCH TRAINING A N D C A PA C I T Y BUILDING Strong and self-sustained TB research capacity within countries is a pre-requisite to achieving national targets towards ending TB. The national TB research plan should include the mechanisms and activities that will strengthen and maintain infrastructure a n d h u m a n r e s e a r c h c a p a c i t y, i n c l u d i n g detailed countr y plans for research training (national and international) in TB, recruitment and retention of investigators, and the necessar y funding commitments. The research plan should take advantage of international funding mechanisms and training opportunities, and include formal agreements with international universities or research institutes wherever possible. Substantial and sustained national funding i s e s s e n t i a l t o t h e p l a n ’s l o n g - t e r m s u c c e s s and impact.
3 2
epidemiological, bio-statistical, social, behavioural, health system and operational research methods. While these training programmes will not exclusively target TB research, they should incorporate adequate opportunities for super vision of students involved in TB research. Many stakeholders are involved in TB research training. The roles and responsibilities of government agencies, universities, medical schools, research institutions and other health professional training programmes should be well d e f i n e d . A d d i t i o n a l l y, t h e d i v e r s i t y provided by private sector and NGO participation will enhance opportunities, support and collaboration. Countries should also expand regional and international partnerships through links with international universities or research institutions, which will help promote student and faculty exchanges and enrichment. Public funding should be made available for a broad range of training, from a few months to several years, depending on academic level. Funding will be needed to support trainees and to develop or strengthen research training programmes in national universities. While countries should take advantage of all available international training and funding opportunities, the importance of sustained national public funding for training cannot be underestimated (see Box 5). It is the best mechanism to ensure training is aligned with national research priorities and available for the longer term.
3 . 1 H E A LT H R E S E A R C H TRAINING TB research training should aim to fulfil a c o u n t r y ’s n e e d f o r h i g h - q u a l i t y r e s e a r c h e r s . It should be part of a larger national plan for health research training and capacity building, since strengthened health research generally can benefit TB r e s e a r c h . Tr a i n i n g s h o u l d b e a v a i l a b l e a t undergraduate and postgraduate levels (MSc and PhD) in fundamental, clinical,
Par ticular challenges for Brazilian science include the need to increase the number of PhDs, strengthen interaction between academia and industr y, promote international collaboration, and increase the number of discoveries leading to patents. To address these challenges, the Government of Brazil introduced the Science without Borders programme in September 2011. Its main goals were to increase the presence of students and scientists in international institutions, encourage young talents and highly qualified researchers from abroad to come work in Brazil, and increase the internationalization of universities. In its first four years, the programme would provide scholarships to 100,000 Brazilian students for academic studies and research. By September 2014 over 70,000 scholarships had been awarded. In July 2014, the President of Brazil renewed the programme, funding an additional 100,000 positions for 2015-19. In the first four years 64,000 undergraduate students and 15,000 doctoral students received scholarships to attend international institutions for up to one year. Funds were also provided for an additional 4500 students for full doctorates abroad, 6440 for post-doctoral studies and 7060 for technological development and innovation studies. The programme also funded 2000 young talents and 2000 visiting scientists from international institutions to work in Brazil. It provides training in 17 areas with the greatest number of awards in Engineering and Technology (46% of positions), followed by Health and Biomedical Sciences with 17% of scholarships. The USA is the preferred destination, with 29% of students, followed by the United Kingdom (13%) and Canada (9%). (http://www.cienciasemfronteiras.gov.br/web/csf-eng/)
A
G L O B A L
A C T I O N
F R A M E W O R K
F O R
T B
B O X 5 / N AT I O N A L LY- F U N D E D R E S E A R C H C A PA C I T Y B U I L D I N G : S C I E N C E W I T H O U T BORDERS, A BRAZILIAN PROGRAMME FOR ACADEMIC MOBILITY
R E S E A R C H
3 3
3 4
© WHO/SEARO/Gar y Hampton
3.2 RECRUITMENT AND RETENTION OF TB RESEARCHERS Sustaining TB research requires retaining a critical number of in-countr y TB researchers a n d e n s u r i n g t h e i r l o n g - t e r m s a l a r y, infrastructure needs and stable national funding support.
‘Scien ce with ou t Borders’ - B ox 5 above) . In th e same spirit, join t P h D par tn ersh ips stu den ts receive a sin gl e qu al if ication f rom both a n ation al u n iversity an d a u n iversity in an oth er cou n tr y ( a join t P h D degree) , wh il e carr yin g ou t research at n ation al l evel ( 10) . In ter n ation al cooperative ef f or t s in operation al research may al so pl ay an impor tan t rol e in n ation al capacity bu il din g ( f or exampl e, th e ‘SORT IT in itiative’ – B ox 6 ) . R E S E A R C H A G L O B A L A C T I O N F R A M E W O R K F O R T B
h ave al ready been created wh ereby P h D
3.3 FORMAL LINKAGES TO ENHANCE CAREER OPPORTUNITIES, MENTORING A N D C O L L A B O R AT I O N D e v e l o pi n g n atio na l hea lth r esea r c h c a pacity i n l o w- a n d m id d le-inc o m e c o untr ies is k ey t o s t re n g t h e n i n g their hea lth system s. F or mal l i n k s be t we e n TB-r ela ted r esea r c her s, tr ain in g i n s t i t u t i o n s , n a tio na l p ub lic hea lth/TB c on trol , i n t e r n a t i o n al r esea r c h a nd tr a ining univ ersities wo u l d al l h e l p r einfor c e na tio na l r esea r ch c ap ac i t i e s . F o r ex a m p le, links b etween re s e a rc h t rai ning institutions a nd the na t ion al TB pro g ra m m e wo uld fa c ilita te the entr y of p ro g ram m e p er so nnel into r esea r c h tr a inin g a n d o f re s e a rc h tr a ining gr a d ua tes into th e TB pro g ra m m e. These for m a l links wo uld al so s u pp o r t re s e a rc h tr a inees fo r field wo r k, an d t ra i n e e s a n d fa c ulty fo r knowled ge tr a ns l ation activities. L i n k s b e t we e n na tiona l r esea r c h tr a ining an d i n t e r n a t i o n al univ er sities a nd institutes c an a l s o p ro v i d e op p o r tunities fo r m ento r ing by a l l o wi n g f a c u lty a t na tiona l univ er sities to re f i n e t h e i r re sea r c h a nd r esea r c h tr a ining s k i l l s a n d g rad ua te stud ents to ex p a nd their
4 / E N S U R E A D E Q U AT E A N D S U S TA I N A B L E O P E R AT I N G F U N D I N G FOR RESEARCH Middle-income high-TB burden countries have the capacity to invest in the full spectrum of TB research, ranging from fundamental to operational research, and should be encouraged to do so by applying the following principles.
4.1 SOURCES OF FUNDING Sustained national public funding is key to a long-term and stable national research c a p a c i t y t h a t i n v e s t i g a t e s a c o u n t r y ’s n a t i o n a l priorities. Funding requires strong political commitment to support TB research as part of general health research, but achieving this commitment means convincing policy-makers and politicians of the importance of TB in the n a t i o n ’s h e a l t h r e s e a r c h s t r a t e g i e s .
3 5
research train in g in -cou n tr y an d abroad ( see
3 6
B O X 6 / I N T E R N AT I O N A L LY- F U N D E D R E S E A R C H T R A I N I N G : T H E S T R U C T U R E D O P E R AT I O N A L R E S E A R C H A N D T R A I N I N G I N I T I AT I V E ( S O R T I T ) Launched in 2012, SORT IT supports countries to: 1) Conduct operational research that addresses their priorities; 2) Develop adequate and sustainable operational research capacity in public health programmes; 3) Increase organisational acceptance of operational research and use of research results to improve programme performance. This global initiative, led by the Tropical Disease Research (TDR) Programme at WHO, supports operational research in TB, as well as a range of other public health programmes including HIV, malaria and neglected tropical diseases. A number of donors actively support SORT IT including DFID, USAID and the Bill & Melinda Gates Foundation. Implementation of SORT IT activities relies upon a strong international partnership of other organisations with experience in operational research, research capacity-building and knowledge management. These include the International Union Against Tuberculosis and Lung Diseases (The Union), Médecins sans Frontières (MSF), KNCV, the US Centres for Disease Control, the Evidence into Policy Network (EVIPNet) and a number of academic institutions. SORT IT partners work closely with ministries of health and the WHO regional and countr y offices to implement multi-phase SORT IT Programmes. These phases include: research prioritization and planning of capacity-building; conduct of prioritized operational research by healthcare workers in the context of a one-year modular training and mentorship programme; publication of research and dissemination of research findings; active engagement with stakeholders to promote translation of research into policy and practice; supporting further operational research by trained healthcare workers through small grants; and building leadership through SORT IT operational research fellowships that can lead to higher degrees. As of mid-2015 more than 300 healthcare workers in over 75 countries had received training, conducted operational research and participated in other SORT IT activities. (http://www.who.int/tdr/capacity/strengthening/sort/about_sort/en/)
capacity building, domestic public funding could be enhanced by partnering with national or international private industr y (for TB diagnostic or therapeutic research, for example) or with international donors, other
Additional domestic funding sources could include regional, provincial or municipal i n d u s t r y, p h i l a n t h r o p i c i n s t i t u t i o n s a n d NGOs. R E S E A R C H
governments, or private entities such as
© WHO
A
G L O B A L
A C T I O N
F R A M E W O R K
F O R
T B
3 7
As is the case with funding for training and
governments and international institutions.
3 8
At the international level, countries receiving suppor t from The Global Fund to F i g h t A I D S , Tu b e r c u l o s i s a n d M a l a r i a ( T h e Global Fund) should be seeking support for operational research directed at improving TB control activities. This includes evaluating the impact of introducing new technologies or TB control strategies into the health system and would require a clear description of the objectives, methods and expected results of research w i t h i n t h e c o u n t r y ’s N a t i o n a l T B S t r a t e g i c Plan. Other international sources of research funding include multilateral or bilateral d e v e l o p m e n t a g e n c i e s , i n d u s t r y, philanthropic donors and partnerships with international investigators, for example through participation in multicentre studies or trials. The annual report o f t h e Tr e a t m e n t A c t i o n G r o u p ( 1 1 ) a n d the GFINDER database are useful sources of information on current international funding sources (source of funding, project funded and countries).
Successful research requires substantial infrastructure, such as well-established institutions with funding specifically for TB research staff and facilities. These institutions offer clear career paths for researchers, stimulate entr y into research and encourage retention of researchers inc o u n t r y. T h e y i n c l u d e u n i v e r s i t i e s , r e s e a r c h institutes, or TB programmes and public health agencies, with funding for laborator y facilities, clinical facilities, and general office, computing and storage facilities for clinical, epidemiological and operational and health systems research. Additional infrastructure needs include access to librar y facilities, other research resources such as non-open access medical journals and payment for open access publications, and costs of presenting research results at national and international meetings. Much of the national funding for TB research should be directed towards the priorities for TB research identified in the national r e s e a r c h a g e n d a s . H o w e v e r, t h e r e m u s t be some flexibility to allow for novel, investigator-initiated ideas, in response to new research findings and directions.
4.2 COMPONENTS SUPPORTED Funding is needed for human resources, including salaries of investigators, administrative and research personnel such as data managers, statisticians, laborator y technicians, research coordinators, inter viewers and research assistants. Personnel with adequate training in r e g u l a t o r y, e t h i c a l a n d q u a l i t y a s s u r a n c e requirements are also needed. Publicly funded health research should be encouraged through an open and transparent competitive process for timelimited grants with external judging by peerreview committees. Countries should refrain from indefinite or lifetime funding to avoid stagnation.
4.3 FUNDING MECHANISMS A N D D U R AT I O N
all phases of the national strategic plan. National NGOs can be of great assistance in advocating for additional funding (see Box 7 ). Advocacy should focus on gaining full government commitment for sustained national public funding of TB research and strengthening community engagement in research, from the design of clinical trials and trial conduct to the deliver y and uptake of successful innovations.
Effective engagement of all stakeholders can greatly enhance investments in research and development - including public and private donors, the scientific community, national TB programmes and civil society. Strong and carefully focused advocacy activities will increase stakeholder engagement in TB
BOX 7/THE ROLE OF NGOs AND OTHER CSOs IN S U P P O R T I N G P I L L A R 3 O F T H E E N D T B S T R AT E G Y N G O s and other Civ il So c iety Or gan ization s ( CSOs) can be key stak eh ol ders in th e p ro m o t i o n of TB r esea r c h p a r tic ula r ly at cou n tr y l evel . NG Os cou l d pl ay a sal ien t rol e in t h e f o l l o w ing suggested a r ea s: •
F o c u s ed a d v oc a c y a c tiv ities to emph asize th e impor tan ce f or en h an ced en gagemen t o f v a rio us sta keho ld er s in TB r esearch at n ation al l evel ;
•
C at al y zing the esta b lishm ent / rein f orcemen t of a n ation al T B research n etwork an d a c t i v e ly p a r tic ip a te in it;
•
A d v o ca ting the d ev elop m ent o f t h e cou n tr y specif ic T B research pl an an d agen da; A d v o ca ting fo r ob ta ining full gover n men t commitmen t f or su stain ed pu bl ic f u n din g of TB re s ea r c h a nd r esea r c h c a p a city bu il din g;
•
•
En g a ging in the im p lem enta tion of th e n ation al research pl an an d agen da an d m o n i t o r ing their im p lem enta tion;
•
St re n gthening c o m m unity enga gemen t in research .
A
G L O B A L
A C T I O N
F R A M E W O R K
F O R
T B
R E S E A R C H
5 / A D V O C AT E F O R PUBLIC SUPPORT AND FUNDING OF TB RESEARCH
and development funding on TB. Stakeholder engagement is an essential activity that must be initiated early and maintained throughout
3 9
research as well as the countr y’s research
6 / I N D I C AT O R S A N D MILESTONES FOR MONITORING AND E VA L U AT I O N 6 . 1 I N D I C AT O R S Progress in implementing the national TB research plan must be monitored and evaluated with relevant indicators and milestones. These should include ‘process’ indicators (how TB research is being strengthened) and ‘content’ indicators (how far the TB research strategy has been developed and its impact on the End TB Strategy targets in each countr y). Ideally the inclusion of some of these metrics in the WHO Global TB Report would stimulate their adoption by NTPs. P r o c e s s i n d i c a t o r s ( Ye s / N o ) i n c l u d e :
4 0
•
Whether national TB research priorities have been developed through a multistakeholder process and are widely disseminated;
•
Whether a national plan exists for health research capacity building, including mechanisms for national funding of health research training and infrastructure;
•
Whether a national mechanism for funding TB research operating costs has been developed.
Content indicators include: •
The number of researchers trained at MSc and PhD levels (in-countr y and abroad);
•
The number of researchers working in research within the countr y five years after training;
• •
The type and amount of research operating funds awarded from national public sources;
Whether a national TB research network has been established, receives funding support from national public sources, and meets regularly; •
The number of publications in international peer-reviewed journals;
•
Whether a plan for TB research has been developed through a multistakeholder process, and is integrated within the National TB Strategic Plan; •
Changes in diagnostic, treatment or preventive policies and strategies of the NTP resulting from domestic research.
DELIVERABLES MID-TERM MILESTONES AND DELIVERABLES (BY 2020) Within 5 years, all countries with substantial TB burden will have: •
DELIVERABLES (BY 2025) W i t h i n 10 years, all countries with substantial TB burden will have: •
research plan with a TB-specific prioritized research agenda within a larger health research agenda, based on mapping of resources and activities, with a process to review and renew it ever y five years; •
network that includes at least leadership from national universities/research institutes, the national TB programme, and civil society; •
Established sustained mechanisms for funding a broad spectrum of research ef for ts on TB (from basic to operational according to the countr y’s resources and research capacity), based on newly developed national research agendas;
Integrated TB research within the National TB Strategic Plan;
•
Developed TB research priorities; Initiated in-countr y research training with national faculty (at a minimum, have the capacity to deliver operational research training). •
•
Created a strong TB research capacity, including training, mentoring and career suppor t, with well-defined roles for government agencies and national TB programmes, universities or research institutions, private sector and NGOs;
•
Empowered a strong and self-sustained TB research community, which is productive, addresses national priorities, and with links to regional hubs and international r e s e a r c h networks.
A
G L O B A L
A C T I O N
Established a national TB research
F R A M E W O R K
Developed and implemented a national TB
F O R
T B
R E S E A R C H
6.2 MILESTONES AND
FINAL MILESTONES AND
4 1
MODEL COUNTRIES
4 2
A few countries already have substantial TB research capacity and may be able to develop and implement a national TB r e s e a r c h p l a n r a p i d l y. T h e s e c o u n t r i e s w i l l achieve milestones more quickly and will ser ve as model countries for TB research. The following one and 5-year milestones and deliverables are proposed:
• Established a national plan for health research capacity building, including mechanisms for national funding of health research training and infrastructure support; • Established mechanisms for regular (such as annual) award of national research operating funds.
F I R S T- Y E A R M I L E S T O N E S A N D DELIVERABLES IN MODEL COUNTRIES (BY 2016) W i t h i n o n e y e a r, m o d e l c o u n t r i e s will have: • F o r m e d a na tiona l TB r esea r c h network t h a t re c e i v es fund ing sup p or t fr o m nation al p u bl i c s o ur c es a nd m eets r egula r ly; • Integrated TB research within the National TB Strategic Plan using a multistakeholder process; • Established annual (or more frequent) • Developed a list of national TB research priorities through a multi-stakeholder process, and disseminated this widely; national competitions for health research operating funds. MID-TERM MILESTONES AND DELIVERABLES (BY 2020) Within 5 years, model countries will have: • Established national funding for TB research capacity including incountr y training at MSc and PhD levels in a variety of disciplines, and for infrastructure including salaries for researchers;
• •
Formed a national TB research network; Integrated TB research within the National TB Strategic Plan; Developed a list of national TB research priorities; Established a national plan for research capacity building; Established mechanisms for regular award of national research operating funds.
•
Established national funding for TB research capacity; Established annual national competitions for health research operating funds.
•
•
•
•
A
G L O B A L
Model countries
Model countries will have:
Model countries will have:
A C T I O N
2016
2020
F R A M E W O R K
D E L I V E R A B L E S AT A G L A N C E
F O R
MODEL COUNTRIES MILESTONES AND
T B
R E S E A R C H
4 3
4 4
PA R T I I
A N D A T
F A C I L I T A T I N G L E V E L
THIS CHAPTER DESCRIBES HOW TO ENHANCE TB RESEARCH G L O B A L LY T O B U I L D I N G S T R O N G R E S E A R C H PA R T N E R S H I P S A N D NETWORKS AND SECURING ROBUST FUNDING FOR TB RESEARCH.
Key activities are: 1. Mobilise increased funding resources for TB research at global and national levels; 2. Hold regular TB research donors’ forum; 3. Develop innovative funding mechanisms;
4. Expand advocacy activities to increase TB research funding internationally; 5. Create international networks and thematic hubs; and 6. Undertake large-scale, crossc u t t i n g , m u l t i - d i s c i p l i n a r y, m u l t i - s i t e , collaborative research projects.
A
G L O B A L
A C T I O N
F R A M E W O R K
G L O B A L
F O R
R E S E A R C H
T B
R E S E A R C H
S U P P O R T I N G
4 5
4 6
Efforts invested at national level must be reinforced and supported at the global level by developing strong research partnerships and networks, associated with reinvigorated funding for TB research and development.
financial shortfall of about US$ 1.4 billion per year according to the Global Plan to Stop TB 2011-2015 (12). TB research is highly dependent on a ver y limited number of donors, including a few government agencies and philanthropic
1/MOBILIZE INCREASED RESOURCES FOR TB RESEARCH Development of new tools and strategies for TB prevention, care and control is hindered by limited investments in TB research. After a significant increase from US$ 358 million in 2005 to US$ 637 million in 2009, global funding for TB research and development has remained static for the last five years (11) (Figure 4). In 2013, US$ 676.5 million were spent globally - a
groups based almost exclusively in highincome countries. This creates a fragile resource base, as government donor agencies face many competing demands for funding and are subject to continuous challenges from emerging priorities. There is a risk that current support by major public donors may stagnate or even decline in the near future, and that private pharmaceutical companies are progressively retreating from research and development of TB drugs. There is therefore an urgent need to increase and diversify investment sources. A series of directions are proposed.
FIGURE 4/FUNDING GAP IN TB RESEARCH
$1.32 BILLION Funding gap
$677 MILLION Funding available
$2 BILLION FUNDING REQUIRED FOR RESEARCH AND DEVELOPMENT TA G T B R & D r e p o r t 2 0 1 3
1.1 EXPAND INTERNATIONAL FUNDING SOURCES TO SUPPORT RESEARCH IN LOW- AND MIDDLE-INCOME COUNTRIES F u n di n g i s n e ed ed for a wid e r a nge o f re s e a rc h , f rom b a sic sc ienc e fo r the d e v e l o p m e n t of new to o ls to the r esea r c h re q u i re d t o e f fec tiv ely sc a le up a nd im p lemen t t h e s e n e w t o o ls. While p ub lic , p r iv a te an d p h i l an t h ro p i c d o nor s c ur r ently c ontr ib ute to f u n d i n g o f TB r esea r c h wo r ld wid e, a lm ost 9 0 % o f g l o ba l TB r esea r c h fund ing c om es f ro m f e we r t h a n 1 0 d o nor s. Ther e is a cl ear n e e d t o e x p and the c ur r ent b a se o f d onors wh o c o n t ri b u t e to TB r esea r c h. P ro m o t i n g o p er a tiona l, hea lth system s or s o c i a l s c i e n c e r esea r c h will help im p r o v e a c t i v i t i e s t o e nd TB a nd c o ntr ib ute to m o re e f f e c t i v e na tio na l p olic ies. WH O wi l l t h e re f o re a d v o c a te with r elev a nt i n t e r n a t i o n al , b ila ter a l a nd p hila nthr o p ic d o n o rs c f o r i n c r ea ses in TB r esea r c h fundin g f o r p ro g ram m a tic a nd op er a tio na l r esea rch , p re v al e n c e a n d d r ug-r esista nc e sur v eys an d h e al t h s y s t e m s r esea r c h, a m ong other s. P a ra l l e l d i s c u s sio ns should ta ke p la c e with al l in t e r n at i o n a l resea r c h institutio ns, d o nor s an d t h e p ri v a t e s e cto r to inc r ea se their c o m mitmen t t o f u n di n g TB r esea r c h in low- a nd m id d l ein c o m e c o u n t r ies.
with key don ors on en h an cin g th e ef f icien c y an d impact of cu rren t in vestmen ts. T h is type to brin g in n ew poten tial f u n ders, reveal th e gaps in T B research an d h igh l igh t areas wh ere th ey cou l d in vest. R E S E A R C H A G L O B A L A C T I O N F R A M E W O R K F O R T B
of discu ssion f oru m cou l d be an oppor tu n it y
1 . 3 . S T I M U L AT E T H E DEVELOPMENT OF I N N O VAT I V E F U N D I N G MECHANISMS Va r io u s n e w m e c h a n i s m s a r e n o w b e i n g explored or implemented to provide incentives for research. One is the ‘riskguarantee’ model (exemplified by the Swedish Guarantee Model) designed to complement and stimulate other financial resources that have the potential to contribute to the goal of poverty reduction and sustainable development. Another is the ‘ G l o b a l T B Va c c i n e P a r t n e r s h i p ’ d e s i g n e d to better align current funders and attract new and innovative funding to support TB v a c c i n e d e v e l o p m e n t . Ye t a n o t h e r a p p r o a c h consists in matching national and externally raised funding, such as the Strategic Health Innovation Partnerships (SHIP) implemented in South Africa (see Box 8). A novel concept for innovative funding, the ‘Push, Pull & Pool’ mechanism, has been developed by MSF and includes a mix of incentives and collective
1.2. HOLD REGULAR TB RESEARCH DONORS’ FORUM In addition to seeking additional funding, countries should aim to improve the use of
management of intellectual property for new T B d r u g d e v e l o p m e n t d. I t i s p r o p o s e d t h a t specific model business cases be developed and discussion fora organized to reflect on these innovative funding mechanisms.
c
For example, The Global Fund, European & Developing Countries Clinical Trial Par tnership (EDCTP), National Institutes of Health (NIH), US Agency for Inter national Development (USAID), UK Depar tment for Inter national Development (DfID), Bill & Melinda Gates Foundation, the Special Programme for Research and Training in Tropical Diseases (TDR) http://www.ms faccess.org/push-pull-pool
d
4 7
existin g f u n din g th rou gh regu l ar discu ssion s
4 8
B O X 8 / I N N O VAT I V E F U N D I N G MECHANISMS: SOUTH AFRICAN MEDICAL R E S E A R C H C O U N C I L - S T R AT E G I C H E A LT H I N N O VAT I O N PA R T N E R S H I P S ( S H I P ) Driven by a pressing need to develop new or improved health inter ventions to address South Africa’s major health problems, the South African Medical Research Council (SAMRC) launched Strategic Health Innovation Par tnerships (SHIP) in 2013. SHIP utilizes funding from the South African Government to leverage international funding. Funds from both these sources suppor t the National Biotechnology Strategy, which fosters research and innovation. The primar y objectives of SHIP are to: (i) Seek, fund, and manage product research development from discover y to proof-of-concept. (ii) Enhance the South African research capacity for development of novel or improved drugs, vaccines and other biologicals, diagnostics and medical devices – for priority diseases. (iii) Facilitate, through par tnerships with local universities, science councils and the private sector, the transfer of research outputs from the laborator y to the marketplace, resulting in improved health outcomes or social benefits. In just over 18 months, this new initiative attracted US$ 70 million in international funding from the Bill & Melinda Gates Foundation, Wellcome Trust, Grand Challenges, Newton Fund and private sector donors. One example is a fund to which SAMRC committed R30 million over three years and which will be matched by funds from the UK Medical Research council (MRC) and GSK, as part of a broader collaboration for scientific research between the UK and South Africa. Currently 45 projects are funded, ranging from vaccine discover y to drugs and diagnostics and health systems strengthening in TB, HIV, malaria and maternal and child health.
1.4 ADVOCACY Advocacy activities should be undertaken at all levels to increase and expand TB research funding both nationally a n d i n t e r n a t i o n a l l y. A t n a t i o n a l l e v e l , patients’ representatives and civil society
organisations (CSOs) should be actively involved. At international level, a similar case should be made to increase national funding for TB research, particularly in t h e B R I C S e, a n d t o e x p a n d i n t e r n a t i o n a l c o m m i t m e n t t o f u n d i n g TB research and development. Research funding should be
e
Brazil, Russia, India, China, South Africa
joint ownership, leadership and trust with mutual benefit. This will facilitate and enhance research, training, infrastructure development and control ef for ts in high-TB burden countries.
variables will be produced and compared to the research needs described in the potential funding gaps identified for specific areas of TB research. R E S E A R C H A G L O B A L A C T I O N F R A M E W O R K F O R T B
International TB Research Roadmap (8), and
2/IMPROVE I N T E R N AT I O N A L C O L L A B O R AT I O N A c t i v i t i e s t o enha nc e inter na tiona l c o l l ab o ra t i o n on TB r esea r c h sho uld a lso be u n de r t ak e n . Th ese inc lud e m a p p ing the main i n t e r n a t i o n al a c to r s in TB r esea r c h, o r gan isin g m e e t i n g s t o p ro m ote r esea r c h c o lla b o r a tion , d e v e l o p i n g i n ter na tiona l r esea r c h network s a n d p ro m o t i n g la r ge-sc a le c o lla b o r a tiv e p ro j e c t s . Th e se a c tiv ities a r e o utlined b el ow.
2.2 COMPILE AN I N T E R N AT I O N A L COMPENDIUM OF FUNDING OPPORTUNITIES A f u n d e r ’s c o m p e n d i u m , i n i t i a t e d b y N I A I D and WHO, is proposed to describe available international sources of TB research funding as well as conditions for accessing this funding, with guidance on the conditions and procedures for grant-making by specific agencies, where appropriate.
2.1 PURSUE AN I N T E R N AT I O N A L M A P P I N G O F TB RESEARCH A number of initiatives have been set to map main actors in health research and development (for example the WHO Health R&D Obser vator y ) (13) with a focus on TB f
2 . 3 S T I M U L AT E T H E C R E AT I O N OF REGIONAL AND S U P R A N AT I O N A L N E T W O R K S Some TB research networks have been organized around specific projects or themes; a few examples include the EDCTP networks of excellence (14), the Southern Africa Consortium for Research Excellence (SACORE) (15), the UK-MRC African i n v e s t i g a t o r s s c h e m e s g , t h e Tu b e r c u l o s i s Va c c i n e I n i t i a t i v e ( T B V I ) h a n d t h e N I H F o g a r t y F e l l o w s h i p s i. B a s e d o n t h e s e a n d other existing networks, large TB research networks could be created to fill geographic or thematic gaps, linking researchers and
r e s e a r c h a n d f u n d i n g ( s u c h a s t h e Tr e a t m e n t Action Group annual report on TB R&D financing) (11). This should be expanded by mapping key institutions and programmes i n v o l v e d i n T B r e s e a r c h g l o b a l l y, a n d matching them to identified research needs and priorities at international and national levels. A global catalogue of TB research
f g h i
h t t p : / / w w w. w h o . i n t / p h i / i m p l e m e n t a t i o n / p h i _ r d _ o b s e r v a t o r y / e n / h t t p : / / w w w. m r c . a c . u k / f u n d i n g / s c i e n c e - a r e a s / g l o b a l - h e a l t h / a r l / h t t p : / / w w w. t b v i . e u h t t p : / / w w w. f i c . n i h . g o v / W O R L D R E G I O N S / P a g e s / S u b S a h a r a n A f r i c a . a s p x
4 9
coupled with increased par tnership built on
by discipline, sites, countr y and other
5 0
B O X 9 / A N E X A M P L E O F I N T E R N AT I O N A L C O L L A B O R AT I V E T B R E S E A R C H : A M U LT I DISCIPLINARY MULTI-SITE RESEARCH S T U D Y O N T B - R E P O R T I N T E R N AT I O N A L The National Institute of Allergy and Infectious Diseases (NIAID) of the US National Institutes of Health (NIH) has long recognized the need for TB research collaboration and coordination, as prioritized in the International Roadmap for TB Research. Par tially in response to this need, NIAID and collaborating biomedical research entities in Brazil, India, Indonesia and South Africa initiated RePORT (Regional Prospective Obser vational Research in Tuberculosis) International. The objective of RePORT International is to provide a platform for coordinated TB research by establishing a common set of standards and definitions, harmonized obser vational cohor ts with well-characterized populations, consolidated bio-specimen banks, and integrated data collection and analysis strategies. A common protocol with corresponding clinical research forms, a manual of operations, data definitions, and other per tinent standards have been developed. These documents, and the study designs developed by RePORT International may eventually ser ve as templates for global collaborative TB clinical research. It is envisioned that each par ticipating countr y will suppor t local research teams to develop RePORT cohor ts, which will be available for clinical studies to address questions of local, regional and international impor tance. Investigators are encouraged to work with colleagues developing national RePORT networks in other countries to under take jointly-developed common protocols, using common standards and practices. Such an approach will enable large clinical research projects and trials (as the need arises) that cannot be under taken by a single group. In essence, the strategy is to create a multi-faceted, collaboratively funded global TB research network that can address impor tant questions with locally and globally relevant answers, which could expand to include additional collaborators in the future.
institutions with programme managers and public health specialists at regional and supranational levels and stimulating multisite research. This would in turn improve efficiency based on local experience and enhance capacity building and knowledge
t r a n s f e r. H u b s c e n t r e d a r o u n d i n s t i t u t i o n s with a particular expertise or capacitybuilding competence could further stimulate collaboration, coordination and learning, creating a powerful opportunity for enabling platforms that could be used across the
© WHO/K. Kelleher
A
G L O B A L
A C T I O N
F R A M E W O R K
F O R
T B
R E S E A R C H
5 1
5 2
world. As an example, this could be a TBcentric bio-informatic platform allowing access to TB-related data (such as array or RNAseq) and providing the tools needed to look at these data. Other data sets, such as epidemiological data sets, might also be housed in such a platform. These tools could provide researchers with modest infrastructures to access sophisticated technologies.
and involving multiple funders (16). For instance, these could be longitudinal studies of patients and households used to identify biomarkers that characterize the various clinically relevant stages of TB, together with studies on how to prevent transmission and disease development (see Box 9). Linking training and capacity development closely to research should be encouraged and will empower local scientists to take leadership of TB research.
2.4 ENCOURAGE LARGESCALE, CROSS-CUTTING C O L L A B O R AT I V E R E S E A R C H PROJECTS Researchers should be encouraged to develop large cross-cutting multidisciplinar y research projects combining basic, translational, clinical, operational, health systems, and public health research, conducted by multi-disciplinar y consortia of academic and research institutions at national, regional or international levels,
In addition, theme-specific scientific meetings assembling key stakeholders (research teams and financial partners, for example) could be organized to investigate t h e c o u n t r y ’s c a p a c i t y t o d e v e l o p c r o s s cutting science projects and their funding. Collaborative and inter-disciplinar y research could also be stimulated through multidisciplinar y scientific meetings (involving the full range of scientists from basic and clinical to epidemiologic and implementation) around specific themes such as preventive treatment or transmission.
W ithin 10 years , it is expected that : •
FIVE-YEAR DELIVERABLES (BY 2020) Within 5 years, it is expected that: •
th eir commitmen t an d in vestmen ts in R & D for TB, (including on TB elimination measures in low-incidence countries); •
At least three new cross-national TB research networks will be established;
global networking on TB research and monitoring the global impact of research advances; •
cross-cutting collaborative studies will be initiated; •
A t l e a s t t w o new inno v a tiv e fina nc ing m e c h an i s m s will b e im p lem ented ; •
an d impl emen ted to en h an ce T B R&D; At least five large scale, multicentre, cross-cutting collaborative research projects will be developed, fully funded and produce relevant results in terms of TB research.
•
F u l l f u n di ng of TB r esea r c h will b e ensu red a t l e as t i n the BR ICS c ountr ies.
A
Novel f u n din g mech an isms wil l be crea t ed
G L O B A L
•
At least three large multicentre and
A C T I O N
Mechanisms will be in place for
F R A M E W O R K
F O R
High -in come cou n tries wil l h ave en h an ced
T B
R E S E A R C H
3/MILESTONES AND DELIVERABLES
T EN-YEAR DELI V ER ABLES (BY 2025)
5 3
5 4
PA R T I I I
O F
W H O
THIS CHAPTER DESCRIBES WHO’S ACTIVITIES IN SUPPORT OF THE FRAMEWORK.
Key activities are: 1. Provide technical assistance to countries for the development and implementation of a national TB research plan in line with the End TB Strategy;
3 . Wo r k w i t h i n t e r n a t i o n a l , b i l a t e r a l and national stakeholders to foster dissemination of research outputs and uptake by countries; 4. Ensure data sharing; 5. Convene meetings and facilitate
2. Develop guidance tools and documents to assist countries in implementing the Pillar 3 of the End TB Strategy;
communication. A Ta s k F o r c e o n G l o b a l T B R e s e a r c h w i l l guide this work and assist in implementing the Global Action Framework.
A
G L O B A L
A C T I O N
F R A M E W O R K
F O R
T B
R E S E A R C H
T H E
R O L E
5 5
5 6
A s r e q u e s t e d b y t h e Wo r l d H e a l t h A s s e m b l y, the WHO Secretariat, led by the Global TB Programme, is promoting the End TB Strategy and supporting its implementation, including its Pillar 3 on research. WHO is therefore committed to supporting the implementation of this Global Action Framework and will support the activities listed in Part II above by providing direct support to specific countries, as requested.
2/FOSTER SUPPORT F O R D I S S E M I N AT I O N OF RESEARCH O U T P U T S A N D U P TA K E BY COUNTRIES A s par t of its n or mative rol e, WHO con du ct s independent evaluations of key research outputs and evidence and makes subsequent policy recommendations for the use of new tools and inter ventions for TB prevention, care and control, such as Xper t MTB/RIF (17), bedaquiline (18), delamanid (19) or treatment of latent TB infection (20). By developing documents and tools for technical assistance, and through collaboration with par tners, WHO suppor ts the introduction of these new tools in countries, their uptake under programme conditions, and subsequent monitoring and evaluation.
1/PROVIDE TECHNICAL A S S I S TA N C E W HO wi l l wor k with c ountr ies, o ther p a r tn ers a n d d o n o rs t o a ssist in d ev elo p ing a nd i m p l e m e n t i n g a na tiona l TB r esea r c h p lan i n l i n e wi t h t he E nd TB Str a tegy, ensur ing t h a t i t i s we l l a ligned with other na tio nal p l a n n i n g do c u m ents. This sup p or t will incl u de d i re c t t e c h n i c a l a ssista nc e (TA ) to c ountries. In a dd i t i o n , dur ing Na tio na l TB Pr ogr a mme re v i e ws , W HO will a ssist in the m onito r in g a n d e v al u at i on of c ur r ent r esea r c h ef fo r ts an d p ro v i d e re c o m m end a tions fo r im p r ov em en ts.
3/ENHANCE D ATA S H A R I N G A c c e s s to research in f or mation in l ow- an d
W HO wi l l de velop a nd d issem ina te guidan ce t o o l s a n d d o c um ents to b e used b y key actors i n c o u n t ri e s ( fo r ex a m p le, “H o w to for m a TB re s e arc h n etwo r k?” o r “H o w to d ev elop a N at i o n a l TB R esea r c h A gend a ?” – see An n ex 2 ) . O n e s u c h to o l to b e d ev elop ed with th e m o d e l c o u n t ri es will help estim a te the c osts of a n at i o n a l TB r esea r c h p la n. W HO wi l l al so c ontinue wo r king with o t h e r ag e n c i e s, suc h a s b ila ter a l a genc ies s u pp o r t i n g v ar ious fo r m s o f na tio na l TB re s e a rc h .
middl e-in come cou n tries cou l d be expan ded by compil in g l arge an d rel iabl e databases th at al l research ers cou l d sh are. WHO will seek su ppor t f or, an d may h ost as n eeded, th is type of data sh arin g in f rastru ctu re. T h es e tran sn ation al data sh arin g pl atf or ms ( with data f rom l arge-scal e cl in ical trial s an d coh or t stu dies, an d f rom gen ome or RNA sequ en cin g stu dies) wou l d be avail abl e to research ers f rom al l cou n tries. Data migh t be h ou sed in in ter-con n ected pl atf or ms an d wou l d in cl u de th e sof tware n eeded f or acces s an d an al ysis. T h is l ow-cost in ter ven tion wo ul d
c o u n t ri e s ac c ess to r esults gener a ted b y h i g h l y s o p h i s t ic a ted tec hno logy.
institute officials, NTP representatives, WHO will convene meetings and fora as described in Parts I & II. WHO will assist with linking countries through the creation of regional and international networks. If requested, WHO will help convene meetings within countries that involve various stakeholders, including national institutions ( M o H , M o S T ) , TA a g e n c i e s , N G O s , f i n a n c i a l partners and CSOs. researchers from low-, middle- and highincome countries, donors, NGOs and CSO representatives. It will meet regularly to review progress and challenges in pursuing this 10-year action framework, as well as assessing the overall role of research progress within the End TB Strategy at countr y and global levels.
A
G L O B A L
A C T I O N
F R A M E W O R K
4/CONVENE MEETINGS A N D FA C I L I TAT E C O M M U N I C AT I O N
W H O ’s G l o b a l T B P r o g r a m m e w i l l e s t a b l i s h a task force to guide WHO in supporting this Global Action Framework. The task force will include national research
F O R
T B
R E S E A R C H
5 7
g i v e re s e a rc h er s fr om lo w- a nd m id d le-income
5 / E S TA B L I S H A GLOBAL TB RESEARCH TA S K F O R C E
5 8
6/MILESTONES AND DELIVERABLES F I R S T- Y E A R D E L I V E R A B L E S (BY 2016) •
Nation al T B Research P l an ”, “How to f or m a n ation al T B research n etwork ”, an d a gu ide to mon itorin g an d eval u ation ( M &E) on research at n ation al l evel , in cl u din g a ‘ch eckl ist f or n ation al T B research ’) ; Participated in trainings on the End TB Strategy organized by WHO regional and countr y offices;
By 2016, WHO will have: •
Posted the Global Action Framework on the WHO/GTB website to ser ve as a guide for work on TB research promotion and global and national support over the next 10 years; • •
Initiated work with potential model countries implementing Pillar 3; Included progress in TB research and achievement of national milestones for model countries in the WHO Global TB Repor t.
•
Organized a TB Research Symposium at t h e Wo r l d L u n g H e a l t h C o n f e r e n c e i n C a p e To w n ( D e c 2 0 1 5 ) , a n d p r e s e n t e d the Global Action Framework and countries’ experience at a meeting with NTP managers;
MID-TERM (5 YEARS) DELIVERABLES (BY 2020) By 2020, WHO will have:
•
E s t a b l i s h e d t h e G l o b a l T B R e s e a r c h Ta s k Force, and held its first meeting; •
Wo r k e d w i t h a t l e a s t t h r e e m o d e l countries, in close collaboration with key national and international stakeholders, to develop and implement a national TB research plan;
•
D e v e l o pe d tools to a ssist in the i m p l e m e n t a tio n o f this Glo b a l A c tio n F ram e wo rk (suc h a s “H o w to d ev elop a
disseminate lessons learned from model countries; •
priorities, that is integrated within the National Strategic Plan; •
the Global Action Framework for TB Research based on lessons learned; •
at national and international levels to expand the funding base for TB research, including the identification of novel funding mechanisms. This funding will support the full spectrum of TB research (from basic to operational) as appropriate for the national TB research priorities;
Published “TB research investment case studies” that will infor m the implementation of the End TB Strategy based on estimates of impact and cost-ef fectiveness of inter ventions in specific settings;
achievement of national milestones for lower- and middle-income countries in the WHO Global TB Report.
strong TB research capacity with enhanced regional and international collaboration;
•
Supported the creation of regional hubs and international networks for TB research;
FINAL (10 YEARS) DELIVERABLES (BY 2025) By 2025, WHO will have: •
•
Included progress in TB research and achievement of national milestones by countr y and globally in the WHO Global TB Report.
Assisted high TB burden countries to d e v e l o p a n d i m p l e m e n t a na tiona l T B
A
•
Included progress in TB research and
•
Assisted countries to create a
G L O B A L
A C T I O N
F R A M E W O R K
F O R
Published an updated version of
Wo r k e d w i t h c o u n t r i e s a n d d o n o r s
T B
R E S E A R C H
•
Organized a multi-countr y meeting to
research plan with TB specific research
5 9
CONCLUSION The ultimate goal of research in TB is to discover new tools and develop novel strategies to improve prevention, diagnosis and treatment of TB. This requires close collaboration between all key stakeholders to guide development and implementation of n e w t o o l s n a t i o n a l l y a n d i n t e r n a t i o n a l l y. T h e success of the End TB Strategy relies heavily on the potential to create optimal synergies among researchers, funders, programmes, health systems, patients and advocacy groups, so that efforts are effectively carried out worldwide for enhanced, properly funded and sustainable research for TB elimination. The implementation of the present Global Action Framework for TB Research will contribute to the creation of a researchenabling environment that fosters and rewards high-quality research (from basic to implementation) and strengthens research capacity in countries with substantial TB burden. This, coupled with efforts to expand resources at global level to discover and develop new tools and facilitate their seamless integration into national programmes, represents a crucial step towards ending the global TB epidemic.
6 0
© WHO/Sam Nutall
REFERENCES 1. World Health Organization. Documentation for World Health Assembly. http://apps.who.int/gb/ebwha/ pdf_files/WHA67/A67_11-en.pdf 2. Kritski A et al. Two decades of research on tuberculosis in Brazil: state of the ar t of scientific publications. Revista de Saúde Pública, 2007;41 (Suppl):9–14. 3. World Health Organization. Global Tuberculosis Repor t 2015. Geneva, 2015. WHO/HTM/ TB/2015.22. http://www.who.int/tb/publications/ global_repor t/en/ 14. Miiro GM, et al. EDCTP regional networks of 4. WHO. Guidelines for sur veillance of drug resistance in tuberculosis. 5th ed., Geneva, World Health Organization (in press). 2015. See also http://www. who.int/tb/challenges/mdr/sur veillance/en/ 5. World Health Organization. The world health repor t 2013: research for universal health coverage. World Health Organization, Geneva, 2013 6. Viergever RF et al. A checklist for health research priority setting: nine common themes of good practice. Health Research Policy and Systems, 2010,8:36PMID:21159163 7. Tomlinson M et al. A review of selected research priority setting processes at national level in low and middle income countries: towards fair and legitimate priority setting. Health Research Policy and Systems, 2011,9:19- doi:10.1186/1478-4505-9-19 PMID:21575144 8. Lienhardt C, Cobelens F. Operational research for TB control: the scope, the needs and the way for ward. International Journal of Tuberculosis and Lung Disease, 2011, 15(1):6-13. 9. WHO and Stop TB Par tnership. An international roadmap for tuberculosis research. WHO, Geneva, 2011. Available at http://www.stoptb.org/assets/ documents/resources/publications/technical/ tbresearchroadmap.pdf 10. Sewankambo N, et al. Enabling Dynamic Par tnerships through Joint Degrees between Low- and High-Income Countries for Capacity Development in Global Health 20. World Health Organization. Guidelines on the management of latent tuberculosis infection. WHO/ HTM/TB/2015.01 http://apps.who.int/iris/bitstream/10665/136471/1/9789241548908_eng. pdf?ua=1&ua=1 19. World Health Organization. The use of delamanid in the treatment of multidrug-resistant tuberculosis: Interim policy guidance. Geneva: World Health Organization; 2014. WHO/HTM/TB/2014.23. http://www.who. int/tb/features_archive/delamanid/en/ 18. World Health Organization. The use of bedaquiline in the treatment of multidrug-resistant tuberculosis: Interim policy guidance. Geneva, World Health Organization; 2013. WHO/HTM/TB/2013.6. http://www.who. int/tb/challenges/mdr/bedaquiline/en/ 17. World Health Organization. Automated Real-time Nucleic Acid Amplification Technology for Rapid and Simultaneous Detection of Tuberculosis and Rifampicin Resistance: Xper t MTB/RIF System Policy Statement. Geneva, World Health Organization, 2011. WHO/ HTM/TB/2011.4 http://whqlibdoc.who.int/ publications/2011/9789241501545_eng.pdf?ua=1 16. Lienhardt C. Fundamental research is the key to eliminate TB. Nature 2014; 507: 401 15. Mandala WL, et al. Southern Africa consor tium for research excellence (SACORE): successes and challenges. Lancet Global Health 2014;2(12):e691-2 excellence: initial merits for planned clinical trials in Africa. BMC Public Health. 2013;13:258. 13. Terr y R, et al. Creating a global obser vator y for health R&D. Science 2014; 345:1302-1304 12. Stop TB Par tnership. Global Plan to Stop TB 20112015. WHO, Geneva, 2010. Research: Experience from the Karolinska Institutet/ Makerere University Par tnership. PLOS Medicine, 2015; 12 (2): e1001784 11. Treatment Action Group. Repor t on Tuberculosis Research Funding Trends, 2005–2013. TAG, New York, 2014.
A
G L O B A L
A C T I O N
F R A M E W O R K
F O R
T B
R E S E A R C H
6 1
6 2
ANNEX 1
SUGGESTED CHECKLIST FOR ASSESSMENT OF TB RESEARCH S I T U AT I O N AT C O U N T RY L E V E L F O R P R E PA R E D N E S S A N D P L A N N I N G
Objective: This checklist is intended to assist countries in conducting an assessment of the TB research situation in order to inform the development of a National TB Research Plan. It can be used by NTP managers, external consultants, or during a monitoring mission. Questions can be answered with a s i m p l e Ye s / N o , b u t s o m e r e q u i r e f u r t h e r explanation. If documents are available to answer some questions, or a section of questions, these should be referred to, or attached.
A
G L O B A L
A C T I O N
F R A M E W O R K
F O R
T B
R E S E A R C H
6 3
6 4
Domain
Questions / assessment
Ye s / N o
Ye s – t o b e strengthened
No – to be established
PLANNING AND PRIORITIZATION
1. Has an inventory of current TB research been conducted in the country in the last 10 years ? If yes, did this inventor y include the following elements: • • a research network with links to NTP? a national health research plan with TB research priorities? funding – for operating, training, infrastructure, and investigators salar y support? list of researchers and institutions involved in TB research? national or international TB research training?
•
•
•
2. Is there currently a national TB research network? If yes: • does it include national and international TB researchers? does it include public health officials, especially TB programme focal points (or managers)? does it include representatives of the private sector – i n d u s t r y, N G O s ? does it focus on all research or is it restricted to certain types (operational, epidemiologic)? is it linked formally with other countries in the region to foster TB/ health research?
•
•
•
•
Domain
Questions / assessment
Ye s / N o
Ye s – t o b e strengthened
No – to be established
• • • • •
training funding development of networks priority setting was the plan developed through a ‘multi-stakeholder’ process? is there a process for regular review and revision of this plan?
If yes at what f r e q u e n c y : 4. Have national TB research priorities been established?* If yes: • by what group? (list stakeholders who were involved) in what year?
• RESEARCH C A PA C I T Y
5. How many full-time TB researchers are there in the country? 0 1-9 10-19 20-29 30-49 50 or more • please list by categories (public institutions, private institutions, p h a r m a c e u t i c a l i n d u s t r y, detached/seconded, others)
A
•
G L O B A L
A C T I O N
F R A M E W O R K
•
does it include the following aspects?
F O R
If yes:
T B
R E S E A R C H
3. Has a national TB research plan been developed? [If yes – please attach document/report]
6 5
6 6
Domain
Questions / assessment
Ye s / N o
Ye s – t o b e strengthened
No – to be established
RESEARCH C A PA C I T Y
6. Are there institutions within the country that have physical facilities and human resources to conduct TB research? If yes: • how many are there, based in the following?
universities: research institutes: TB programmes/public health programmes: Other (specify): • how many are considered national centres for TB research?
RESEARCH TRAINING
7. Do any national universities offer graduate training in health research? If yes: • • • a t M a s t e r ’s l e v e l ? at PhD level? are any of these specifically targeted to TB research? is there graduate-level training in clinical/ epidemiological/biostatistical research? is there graduate level training in basic research (e.g. molecular b i o l o g y, g e n e t i c s , immunology)?
•
•
8. Are there formal links between the T B p ro g r a m m e a n d national universities/ institutes for graduatelevel research training? If yes: with which universities:
Domain
Questions / assessment
Ye s / N o
Ye s – t o b e strengthened
No – to be established
•
is the mechanism competitive and peerreviewed? is the competition: annual/twice a year/ other? for how many years has this funding mechanism been in place? what is the total value awarded annually (amount and currency)?
•
•
what is the source of funding (ministr y/ national agency providing funding)? any other ministr y? If yes, specify
•
is there any other mechanism? If yes, specify
10. Are there other sources for health (or TB specifically) research funding? If yes, specify 11. Is there national funding for TB research infrastructure (facilities, equipment, human resources)?
A
G L O B A L
•
A C T I O N
•
F R A M E W O R K
If yes:
F O R
T B
R E S E A R C H
RESEARCH FUNDING
9. Is there a mechanism for national (public) funding of operating funds for TB research (to which health research and TB researchers may apply)?
6 7
6 8
Domain
Questions / assessment
Ye s / N o
Ye s – t o b e strengthened
No – to be established
12. Is there a national (public) programme explicitly for salar y suppor t of TB researchers (or health researchers)? If yes: • is it based in universities or research institutes (i.e. block funding to these institutions who then hire researchers on contract)? is this national competitive funding for salar y support for TB/ health researchers? is the mechanism open and peer-reviewed? is the competition: annual/twice a year/ other? for how many years has this funding mechanism been in place? what is the total value awarded annually (amount and currency)?
•
• •
•
•
•
which ministr y or department is providing funding?
•
any other ministr y or department? Specify:
•
other mechanism or department? Specify:
13. Is there national funding to suppor t TB (or health) research training? If yes, • • • a t M a s t e r ’s l e v e l at PhD level only at national universities (in-countr y training) at national and international universities
•
Domain
Questions / assessment
Ye s / N o
Ye s – t o b e strengthened
No – to be established
If yes: • • since what year? what is the amount for TB? (specify average a m o u n t a n n u a l l y, a n d currency)
•
is there any funding allocated for TB research in the current Global Fund award?
If yes: How much? (specify average annual amount in past 5 years, and currency):
•
what percentage of total Global Funds disbursed in the countr y go to TB research? is this only for operational research? if other types of research – specify:
•
•
16. Are there other substantial and regular external sources of research funding? If yes: • specify source(s)
•
average annual amount and currency (if known):
A
G L O B A L
A C T I O N
F R A M E W O R K
15. Does the countr y receive funding from the Global Fund?
F O R
T B
R E S E A R C H
14. Is there funding available from national industries (drugs/ diagnostics/vaccines) to suppor t TB research?
6 9
7 0
ANNEX 2
F O R M I N G A N AT I O N A L T B R E S E A R C H N E T W O R K Objectives: 1 . To c o o r d i n a t e T B r e s e a r c h n a t i o n a l l y, including identification of research needs and communication of results between d i f f e r e n t s e c t o r s w i t h i n t h e c o u n t r y, including public health/TB programme, academia, public and private institutions; 2. To facilitate collaboration between dif ferent par tners and stakeholders, as well as dif ferent disciplines at national level; 3 . To a d v o c a t e f o r i n c r e a s e d s u p p o r t f o r TB research from public (government) 5 . To p a r t i c i p a t e i n m o n i t o r i n g a n d evaluation of research and research c a p a c i t y, a n d i n r e g u l a r r e v i e w s o f t h e national plan and priorities (at minimum ever y five years). 4 . To p a r t i c i p a t e i n s t r a t e g i c p l a n n i n g a n d help develop the National TB Research Plan, including development of national TB research priorities; a n d p r i v a t e ( i n d u s t r y, N G O s a n d philanthropic societies) sources;
A
G L O B A L
A C T I O N
F R A M E W O R K
F O R
T B
R E S E A R C H
7 1
MEMBERSHIP AND LEADERSHIP OF T H E N AT I O N A L T B RESEARCH NETWORK This network should be as inclusive and multi-disciplinar y as possible. It should include researchers from a broad range of disciplines (such as clinical, operational, e p i d e m i o l o g y, g e n e t i c s , a n d i m m u n o l o g y ) . Representatives from universities, research institutions, biomedical associations and government agencies such as public health officials, especially TB programme managers, should be included. Representatives of nursing and other allied health professions should be invited, as well as community and civil society representatives and NGOs. Representatives of the private sector including practitioners and industr y should also be invited to participate. The NTP should consider designating someone within the programme to be a TB research focal point; this person should receive training or have a background in research. The network should also include researchers and institutions from other countries involved in collaborative research activities, as well as donors. Links with TB research networks in other countries should be encouraged or reinforced to create regional networks and foster regional projects in TB research. The network could also be usefully linked to international TB research networks addressing specific disciplines or research themes.
7 2
Representatives from different groups should initially be appointed for three to four years and then encouraged to rotate, allowing other persons from their institution or group to participate in the network. Leadership of the network should be rotated regularly and often (for example ever y two years). It is suggested that leadership should alternate between members from different groups to ensure all major groups are represented at the leadership level. This is best done by writing a brief ‘constitution’ outlining rules of leadership, and by a leadership vote open to all members of the network.
ACTIVITIES AND RESPONSIBILITIES OF THE NETWORK In general, the activities of the network will be aligned with its objectives. Each countr y will have to develop its own terms of reference and mode of operations for the network. The frequency and duration of meetings will depend on practical issues such as resources to support these activities. To a d d r e s s t h e s p e c i f i c o b j e c t i v e s l i s t e d above, the following activities are suggested: 1. Coordinate TB research: Organization of regular meetings assembling all members of the network who will provide updates on their activities. At
be organized to disseminate research results by network members to all other members and discuss scientific questions of interest. Particular emphasis should be placed on presenting results of projects that are crosscutting or judged likely of interest to others within the network. 2. Facilitate collaboration between different partners, stakeholders and disciplines: A s p a r t o f t h e n e t w o r k ’s m e e t i n g s a n d w i t h the help of the Secretariat, ensure that all members of the network are aware of any potentially relevant call for proposals from national and international sources. Encourage collaboration in responding to these calls. Advocate with policy-makers on the importance and value of multidisciplinar y research (to encourage funding of this type of research). 3. Advocate for increased support for TB research: Develop strategies to raise awareness at all levels of government and among private funders on the value of health research, and especially TB research. Develop case studies where research findings were applied to clinical practice and led to health or financial benefits. 4. Participate in strategic planning: An important activity is to assist in the development of the National TB Research
inventor y of TB-related research is needed. The network should be involved, at least in inventor y is completed and the TB research plan developed, the network will participate in the development of detailed countr yspecific TB research priorities. 5. Participate in monitoring and evaluation: The network will also carr y out updates of the National Strategic Plan and the research priorities through regular reviews. Revisions should be performed, at minimum, ever y five years. R E S E A R C H A G L O B A L A C T I O N F R A M E W O R K F O R T B
a n a d v i s o r y r o l e , i n t h i s a c t i v i t y. O n c e t h e
RESOURCES FOR THE NETWORK: Network activities revolve primarily around meetings and communication. While it is best that members pay their own way to meetings, this may lead to under-representation of c e r t a i n g r o u p s , p a r t i c u l a r l y c i v i l s o c i e t y. As a result, a minimum of funding will be required to support attendance at meetings, and ideally some additional funds for the necessar y administrative support for the m e e t i n g ’s o r g a n i z a t i o n , c o r r e s p o n d e n c e , m i n u t e s , e t c . T h i s s h o u l d , h o w e v e r, b e s e e n as a rather low-budget activity to which members volunteer their time and, where possible, their travel.
7 3
least one scientific meeting annually should
Plan. Even before this can be started, an