Annual Report Research Capacity Strengthening and Knowledge Management

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1 Annual Report 2015 Research Capacity Strengthening and Knowledge Management

2 TDR/RCS/16.1 Copyright World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2016 All rights reserved. The use of content from this information product for all non commercial education, training and information purposes is encouraged, including translation, quotation and reproduction, in any medium, but the content must not be changed and full acknowledgement of the source must be clearly stated. A copy of any resulting product with such content should be sent to TDR, World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland. TDR is a World Health Organization (WHO) executed UNICEF/UNDP/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases. The use of any information or content whatsoever from it for publicity or advertising, or for any commercial or income generating purpose, is strictly prohibited. No elements of this information product, in part or in whole, may be used to promote any specific individual, entity or product, in any manner whatsoever. The designations employed and the presentation of material in this information product, including maps and other illustrative materials, do not imply the expression of any opinion whatsoever on the part of WHO, including TDR, the authors or any parties cooperating in the production, concerning the legal status of any country, territory, city or area, or of its authorities, or concerning the delineation of frontiers and borders. Mention or depiction of any specific product or commercial enterprise does not imply endorsement or recommendation by WHO, including TDR, the authors or any parties cooperating in the production, in preference to others of a similar nature not mentioned or depicted. The views expressed in this information product are those of the authors and do not necessarily reflect those of WHO, including TDR. WHO, including TDR, and the authors of this information product make no warranties or representations regarding the content, presentation, appearance, completeness or accuracy in any medium and shall not be held liable for any damages whatsoever as a result of its use or application. WHO, including TDR, reserves the right to make updates and changes without notice and accepts no liability for any errors or omissions in this regard. Any alteration to the original content brought about by display or access through different media is not the responsibility of WHO, including TDR, or the authors. WHO, including TDR, and the authors accept no responsibility whatsoever for any inaccurate advice or information that is provided by sources reached via linkages or references to this information product.

3 RCS/KM Annual Report 2015 Page 3 Table of contents 1. Introduction Overall objective and expected results for Key achievements in Progress in 2015 and planned activities for 2016/ Research capacity strengthening... 8 Regional approach... 8 Small grants... 8 Priority research areas for the AFR call (18 applications, 8 funded)... 9 Priority research areas for the EMR call (40 applications, 10 funded)... 9 Priority research areas for the AMR/PAHO call (46 applications, 8 funded) Priority research areas for the WPR call (68 applications, 15 funded) Priority research areas for the EURO call (15 applications, selection in process) Postgraduate and postdoctoral grants in LMICs International postgraduate training scheme Postdoctoral training scheme Regional Training Centres (RTCs) supported by TDR Training programmes Good health research practice Short term training (IMPACT) grants TDR Career Development Fellowship (CDF) programme Results of the first EDCTP TDR joint selection Second EDCTP TDR joint selection CDF network Developing a framework for core competencies in clinical research Implementation research Access and delivery of the Global Health Innovative Technology (GHIT) fund TDR Global engaging TDR alumni and experts community Gender equity Scheme to improve the careers of women research scientists Knowledge management Gap analysis and agenda setting Capacity strengthening to bring research into policy Partnership and engagement ESSENCE on health research financial implementation revised planned costs TDR funding in

4 4 Page RCS/KM Annual Report Introduction On 1 January 2016 the world entered the Sustainable Development Goals (SDGs) era, ending a fifteen year push to achieve the Millennium Development Goals (MDGs). The transition between the MDGs era and the SDGs era marks an important turning point in global development. The SDGs look set to act as a powerful tool for focusing the world s efforts on tackling poverty, inequality and disease. As part of overall efforts directed at sustainable development, the drive towards ending the epidemics of infectious diseases of poverty will require a focus on several key areas, including research. Realising the full potential of research to contribute towards attainment of health targets depends on strengthening research capacity in the disease endemic countries (DECs), so that the best possible tools are developed to control infectious diseases and are made widely available to the communities that need them. In this regard TDR plays a significant role, in line with its mission to foster an effective global research effort on infectious diseases of poverty and promote the translation of innovation to health impact in disease endemic countries. Research (including the research supported and promoted by TDR) has underpinned the substantial progress made towards the MDGs and will underpin the progress looking towards the SDGs. The Research Capacity Strengthening (RCS) activities focus on strengthening research capacity at individual and institutional levels and the knowledge management and partnership activities support this. The goal is effective implementation of existing and new interventions in low and middleincome countries (LMICs). This report on the work of the RCS/KM team reflects the team s three strategic tasks: 1. Research capacity strengthening: supporting training, leadership development and withinproject strengthening to increase countries ability to respond to their own research needs; 2. Gap analysis for agenda setting: promoting evidence based priority setting to identify emerging needs in research and capacity strengthening; 3. Partnership and engagement: collaborating with WHO departments, TDR co sponsors and partners to achieve harmonization and alignment with global health goals. The TDR Scientific and Technical and Advisory Committee (STAC) at its meeting from March 2015 and the Joint Coordinating Board (JCB) at its meeting from June 2015 reviewed the RCS/KM activities undertaken in 2015 and approved the continuation of the main RCS/KM activities looking forward to the biennium. The continuity of successful RCS activities from the biennium to the biennium reflects the need for a long term approach to the long term issue of strengthening research capacity in disease endemic countries. The management of the implementation of the activities reflects the ongoing experience gained and the input of the Scientific Working Group (SWG).

5 RCS/KM Annual Report 2015 Page 5 2. Overall objective and expected results for 2015 Overall objective: to develop a sustainable health research environment and harmonize global research efforts on infectious diseases of poverty, aiming for enhanced leadership of DECs in health research. Expected results for 2015: Agreed priorities and research agenda used by disease endemic countries. Analyse gaps and needs for agenda setting in research and capacity building. Sustainable health research capacity in disease endemic countries developed and facilitating innovation and translation of research into policy and practice. Promote institutional and individual leadership in health research through postgraduate and postdoctoral grants, small grants, short term training (IMPACT) grants, and development of Regional Training Centres supported by TDR. Global/regional stakeholders and major funding agencies use TDR facilitated tools and reports to inform policy and/or practice. Harmonization and alignment of efforts for global health research by convening stakeholders (including donors, LMIC research structures, and peer organizations) to agree on common policies and practices, and share priorities. 3. Key achievements in 2015 Key achievements in promoting the effective implementation of existing and new interventions in LMICs included the following activities: Re orientation of the postgraduate training scheme to bring research capacity strengthening closer to the disease endemic regions and maximize opportunities for institutional and individual research capacity strengthening. 43 grants to researchers in LMICs for short term training. This was the third round of the IMPACT grant scheme to strengthen capacity in implementation research. Increased TDR regional presence. This includes the renewal of the small grants scheme in collaboration now with all six WHO Regional Offices and completion of the global network of six Regional Training Centres (RTCs) supported by TDR to conduct and disseminate training courses. The last one was selected for the Eastern Mediterranean Region in Tunis, Tunisia. Key training materials and approaches developed to help equip researchers to undertake implementation research (IR): initiation of the Massive Open Online Course (MOOC) on IR and completion of: the basic course on implementation research (IR) developed in conjunction with the RTC in Ghana; the training module on the ethics of IR; and guidance on reporting IR in collaboration with two WHO departments (Knowledge, Ethics and Research; and HIV) and the Alliance for Health Policy and Systems Research. Gender equity promotion: development of a training course on gender based analysis for vector borne disease research is in progress through the RTCs and three projects addressing challenges and barriers for women researchers in LMICs (both in collaboration with VES).

6 6 Page RCS/KM Annual Report Progress in 2015 and planned activities for 2016/2017 Table of expected results with indicators and targets The following table provides a quick overview of the expected results, and updates on meeting targets. Expected results by outcome Outcome 2.1 (Research capacity strengthening): Sustainable health research capacity in disease endemic countries developed and facilitating innovation and translation of research into policy and practice Strategic support to WHO regional activities and networks: i) small grants programme operational in regional offices; ii) regional capacity centres strengthened and active Targeted research training grants in lowand middle income countries: early career and advanced global health targeted support with focus on least developed countries Short term training (IMPACT) grants to improve disease control Advanced training in clinical product development: career development fellowship grants Indicators and targets By 2017, 75% of the innovative knowledge, new/improved solutions or implementation strategies developed are successfully applied in developing countries By 2015, at least 50 small grants awarded, addressing health research priorities in WHO regions 41 small grants awarded in 2015 through collaboration with WHO Regional Offices (awards in EURO in process) (38 small grants awarded in 2014) One Regional Training Centre now established in each of the 6 WHO Regions (AFR, AMR, EMR, EUR, SEAR and WPR) By 2015, 30 to 40 trainees progressing in early career and advanced global health training programmes Postgraduate scheme established in 2015 involving 7 universities in which TDR is supporting 74 fellows (67 Masters and 7 PhD) in its first year Postdoctoral pilot training scheme established in 2015 hosted by Noguchi Institute in Accra, Ghana, in which TDR is supporting 4 fellows in implementation research training By 2015, 20 to 30 * short term training (IMPACT) grants awarded 42 short term training (IMPACT) grants awarded in 2015 By 2015, 15 to 35 * grants ongoing during the biennium 23 Career Development Fellowship grants awarded in 2015 through joint TDR EDCTP scheme (18 funded by TDR) * the higher value reflects the target for US$ 60 million budget scenario

7 RCS/KM Annual Report 2015 Page 7 Expected results by outcome TDR alumni and experts network to follow up on the long term career impact of TDR training and research grants Outcome 2.2 (Gap analysis for agenda setting): Agreed priorities and research agenda used by disease endemic countries) (updated in 2015) ) Complete a review in the area of IR/OR to further map partners, priorities, ongoing activities and TDR s niche within the area. Includes a new method for defining IR/OR. 2) Complete a review in the area of research capacity development approaches, including experiences, results, priorities and recommendations. 3) Integrate the TDR priority setting with the proposed WHO health R&D Observatory (updated in 2015) 1. Strengthen capacity in LMICs to bring research evidence into policy through training and workshops. 2. Create outputs e.g. policy briefs and recommendations on selected topics aligned with priorities in TDR and WHO technical programmes as appropriate. 3. Facilitate improvements in research cooperation through better sharing of research findings and data. Indicators and targets By 2015, database developed and concept tested Network requirements established, network developer identified and database developed, with work on the platform in progress Document developed on Key enabling factors in effective and sustainable research network to inform good networking practices. Strengthen capacity in LMICs to bring research evidence into policy. Create outputs e.g. policy briefs and recommendations on selected topics aligned with priorities in TDR and WHO technical programmes as appropriate. By 2015, reports finalized and published One report completed to inform a scoping review in the area of IR/OR to further map partners, priorities, ongoing activities and TDR s niche within the area. One report published in 2015 based on a scoping review in the area of research capacity development approaches, including experiences, results, priorities and recommendations. TDR priorities are to be integrated within the WHO R&D Observatory to be launched January Training provided to 24 SORT IT fellows and representatives of 11 African countries as part of EVIPNet programme. Methodology validated by pilot testing, peer review and published (figures being collated) Ongoing project with SORT IT fellows in EURO. C PATH chosen to host 4 x TB clinical trial data.

8 8 Page RCS/KM Annual Report 2015 Expected results by outcome Outcome 2.3 (Partnership and engagement): Global/regional stakeholders and major funding agencies use TDR facilitated tools and reports to inform policy and/or practice Collaborative networks for harmonization of policies and practices: i) harmonized principles, policies, standards and practices; ii) expansion with new stakeholders such as emerging research councils, national institutes, universities * and pilot countries Strategic engagement in global health initiatives and networks Indicators and targets By 2017, 7 new tools and reports are used to inform policy and/or practice of global/regional stakeholders or major funding agencies. In 2015, one new practice/standard agreed (impact of global health research on development) and one revised (monitoring and evaluation framework) by ESSENCE. In 2015, joint ECDCTP/TDR/MRC (UK) call issued on strengthening capacity for research on emergencies. Consultation held in Geneva from 9 10 December 2015 on Promoting implementation and operational research in countries receiving grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria. 4.1 Research capacity strengthening REGIONAL APPROACH RCS has expanded a regional approach with the objective of strengthening the conduct of national research which can improve the health care of a country s poorest inhabitants. This approach helps to ensure efficient and effective allocation of TDR's limited capacity building resources, focusing on identified health research needs with maximum potential impact at country/regional levels. In addition, it facilitates cooperation between neighbouring countries and promotes coherence and synergy in capacity building activities developed by different donors in the same region. Small grants TDR has a history of schemes supporting researchers in the WHO regions through small grants (ranging from US$ to US$ ). In 2014, the programme was restructured so that each region took more responsibility for jointly identifying with TDR the research priorities to be funded. It also expanded so that for the first time, all WHO regions were included. New calls are planned in all six regions. A tool will also be developed in collaboration with all regions to assess the outputs, established collaborations and links to public health impact of the small grants supported since Below is a list by region of priority areas of calls (developed in collaboration with each regional office) and the number of applications received and funded in the higher value reflects the target for US$ 60 million budget scenario

9 RCS/KM Annual Report 2015 Page 9 Priority research areas for the AFR call (18 applications, 8 funded) The current Ebola outbreak has underscored the importance of having a functional health system in countries of the African Region. A functional health system prepares communities, health workers, and local and national government authorities for not only emergencies but also for acceleration towards Universal Health Coverage (UHC). Thus, conducting a system diagnosis to identify key bottlenecks across each of the health system building blocks is one of the major priorities for the African Region. This grant supported implementation research for infectious diseases of poverty in the context of health systems strengthening. Proposals had to include the collection of evidence on best approaches to service availability, functionality and readiness assessments of health systems for outbreaks of infectious and neglected tropical diseases, with a particular focus on the most vulnerable populations. Priority research areas for the EMR call (40 applications, 10 funded) Proposals had to include one of the following areas: Tuberculosis Intervention and IR to evaluate new tools (e.g. rapid diagnostic tests, new drugs, shorter regimens) for diagnosis and treatment of TB. Innovative interventions to increase TB case detection including co infections (e.g. TB/HIV). Evaluation of new models/interventions for ambulatory multidrug resistant TB (MDR TB) treatment. Research in the field of TB elimination. Malaria Evaluation of innovative strategies for effective involvement of various types of private providers with the aim of ensuring quality through a combination of regulation, communication, monitoring of products and services and involvement in malaria surveillance. Studies on P. vivax burden in African countries of the Eastern Mediterranean Region through a combination of community prevalence surveys (also using PCR) and health facility studies, especially in the endemic countries multi country study in Djibouti, Somalia and Sudan are encouraged. Research on Glucose 6 phosphate dehydrogenase (G6PD) deficiency prevalence assessing different methods of testing to guide treatment with primaquine, especially in malaria elimination and in malaria free EMR countries. Leishmaniasis Intervention and IR to evaluate effectiveness of topical treatment (cream) for cutaneous leishmaniasis due to L. tropica. Studies evaluating innovative preventive measures against leishmaniasis. Schistosomiasis Studies on sensitive transmission assessment techniques for certification of the interruption of transmission of schistosomiasis in former controlled foci. These techniques may be applied on humans, snails or water.

10 10 Page RCS/KM Annual Report 2015 Priority research areas for the AMR/PAHO call (46 applications, 8 funded) Proposals had to include one of the following areas: Tuberculosis Evaluate new tools for diagnosis and treatment of tuberculosis (e.g. rapid diagnostic tests, new drugs, shorter regimens, etc.) Develop strategies to integrate and deliver joint TB/HIV interventions, including antiretrovirals, at the community and health sector level, to TB/HIV co infected patients. Create innovative operational models for active and enhanced tuberculosis case detection, including co infections with other diseases/conditions (e.g. TB/HIV; TB/diabetes, TB/ mental health, TB/alcoholism, TB/tobacco smoking). Evaluate new models/interventions for implementation of ambulatory multi drug resistant TB (MDR TB). Develop system for MDR TB contact tracing and prevention treatment. Operational strategies to shorten the time from disease onset to diagnosis and treatment, which is crucial in decreasing transmission. Malaria control and elimination Develop epidemiological surveillance formulary and data base information systems, including standards of operation for the use of the data collection system. This could include better traveling history, molecular classification of parasites, details of treatment success and follow up, contact tracing and e Health procedures use of cell phones, internet and tablets. Develop effective and feasible strategies for ensuring quality case management and engagement in case reporting in endemic areas. Engage the community for malaria control and elimination. Develop strategies for identifying and providing services, including vector control, in support of malaria elimination among mobile and remote groups. Evaluate massive screening and treatment (MSAT). Neglected infectious diseases Conduct epidemiological and entomological study of visceral leishmaniasis at the border area of Bolivia and Brazil. Produce training on leishmaniasis diagnostic to strengthen institutional capacity on parasitology and molecular biology Evaluate vector control strategies of leishmaniasis by chemical control and/or environmental management. Document historic and current geographic distribution and prevalence of Strongyloides stercoralis in Latin American and the Caribbean (LAC) countries with experience in its prevention, treatment and control, and its estimated impact on human health in the LAC region. Develop or use sensitive transmission assessment techniques (individual or combined) for the verification of the interruption of transmission of human schistosomiasis (S. mansoni) and/or filarial infections (lymphatic filariasis and human onchocerciasis) in former geographic foci in the Americas that are now controlled. These techniques may be applied to human populations or other hosts (insect vectors, snails), or water sources which the vector uses. Develop historical and current geographical distribution of the invasive African land snail, Achatina fulica, in the Latin American and the Caribbean Countries, being the intermediate host and vector of the rat lungworm Angiostrongylus contonensis, and its impact on human health in the LAC region. Develop strategies to increase the active search and early case detection of leprosy.

11 RCS/KM Annual Report 2015 Page 11 Conduct operational research on ways of identifying appropriate groups of leprosy contacts for counselling, examination and treatment (when necessary), possibly in conjunction with chemoprophylaxis. Pilot projects implementing leprosy chemoprophylaxis under routine programme conditions to assess acceptability, cost effectiveness, feasibility, and ethical issues. Develop new or improved strategies for increasing the adherence to treatment and the cure rates of leprosy patients. Priority research areas for the WPR call (68 applications, 15 funded) Proposals had to include one of the following areas in the prevention and control of infectious diseases of poverty, including malaria, tuberculosis and neglected tropical diseases such as dengue, lymphatic filariasis, soil transmitted helminthiasis, food borne trematode infections, schistosomiasis, echinococcosis, cysticercosis, leishmaniasis, yaws, trachoma and leprosy. Knowledge gap related to an operational/programmatic issue that has a direct policy and programmatic relevance. Health systems, health service delivery, community based approaches or qualitative research topics in the context of the diseases listed above. Priority research areas for the EURO call (15 applications, selection in process) Proposals had to include one of the following areas: Prevention and control of infectious diseases, including elimination of malaria, tuberculosis and neglected tropical diseases relevant in the region. Health systems including health service delivery and community based approaches, or qualitative research topics in the context of the infectious diseases Drug resistance. Emerging infectious diseases. Co morbidity of infectious diseases with non communicable diseases. Postgraduate and postdoctoral grants in LMICs TDR is helping to develop a critical mass of health researchers from low and middle income countries (LMICs). The goal is for them to meaningfully contribute to setting research agendas and conduct research related to priority health issues in their countries. In 2015 TDR focused its ongoing grants leading to MSc and PhD degrees and of grants for post doctoral research on disciplines relevant to implementation research (IR). This generally involves a multi disciplinary approach related to public health programmes. The aim is to develop a cadre of researchers addressing implementation bottlenecks, identifying optimal contextual approaches and promoting the uptake of research findings. International postgraduate training scheme The scheme underwent reorientation in approach in 2015, involving direct collaboration with universities in LMICs to train MSc and PhD students in subjects or disciplines relevant to IR, with the aim of strengthening not only individual but also institutional capacity. Through an open competitive process, TDR selected seven universities in LMICs to host and manage the fellowship scheme, with each university managing up to 10 postgraduate fellows supported by TDR per year. The aims of the scheme are to: Increase the numbers of scientists in LMICs trained in IR on infectious diseases of poverty Support the development of implementation research as a field of study

12 12 Page RCS/KM Annual Report 2015 Increase the capacity of universities in LMICs to provide this curriculum, manage training grant schemes and mentor students Expand the reach of this type of education and training in a systematic process The seven universities are: 1. BRAC University, Bangladesh 2. Universidad de Antioquia, Medellin, Colombia 3. University of Ghana, Accra, Ghana 4. Universitas Gadjah Mada, Yogyakarta, Indonesia 5. American University of Beirut, Lebanon 6. University of The Witwatersrand, Johannesburg, South Africa 7. University of Zambia, Lusaka, Zambia The fellows have been selected in collaboration with TDR through each university s graduate admission process by open competition. These universities are managing a total of 74 postgraduate fellows (67 Masters and 7 PhD) with TDR support in the first year. Postdoctoral training scheme In 2015, TDR identified the Noguchi Memorial Institute for Medical Research (NMIMR), University of Ghana, to pilot a postdoctoral training programme for LMIC researchers. The scheme, which is specifically for IR, builds on 2 foundations. The first is the well established 2 year postdoctoral programme in biomedical research for young African scientists that is funded by the Bill & Melinda Gates Foundation. The second is the Institute s track record in collaborative IR in Ghana with the 3 regional research centres in Navrongo, Kintampo and Dodowa of the Ghana Health Service (GHS) and the Ministry of Health. Regional Training Centres (RTCs) supported by TDR A network of Regional Training Centres supported by TDR and selected on a competitive basis serves to conduct and disseminate training courses relevant to the TDR strategy, e.g. on ethics and good research practices in health research and implementation research. Regionalization of short courses using train the trainer (TtT) methodology and training workshops enables TDR to work more closely with the end users and become more relevant to regional needs, empower centres based in the regions to serve as training hubs and utilize existing expertise in disease endemic countries (DECs). The four RTCs supported by TDR since are the following: Americas: Centro Internacional de Entrenamiento e Investigaciones Médicas (CIDEIM), Cali, Colombia (training expertise in research project management) South East Asia: Gadjah Mada University (GMU), Jogyakarta, Indonesia (training expertise in social science and implementation research) Europe Astana Medical University (AMU), Astana, Kazakhstan (bioethics training expertise) Western Pacific Research Institute for Tropical Medicine (RITM), Manila, Philippines (expertise in Good Clinical Practice (GCP)/Good Clinical Laboratory Practice (GCLP) and in scientific writing) In 2014, The School of Public Health at the University of Ghana in Accra was selected as the RTC in the African Region with training expertise in IR. Training programmes will be developed based on both the contents of the IR toolkit developed by TDR and the School s own courses in IR. In 2015, the Pasteur Institute in Tunis, Tunisia, was selected as a RTC in the Eastern Mediterranean Region for its expertise in good health research practice.

13 RCS/KM Annual Report 2015 Page 13 RTCs have been also involved in training programmes on IR. This includes the Massive Open Online Course (MOOC), a basic course on methodologies used in IR and more advanced training programmes such as the IR toolkit and ethics in IR, which aim to improve access to and delivery of public health tools, strategies and interventions. TRAINING PROGRAMMES Good health research practice RTCs have progressively integrated a panel of skill building courses for bioethics, good practices, project planning, management and evaluation and dissemination of results within their training programmes. The long term goal is the establishment of a global network of RTCs with common, high quality training courses to foster collaboration and exchange of experiences in the area of good practices in health research and innovative approaches to ensure sustainable capacity development, including distance learning programmes. RTCs are appropriate vehicles for implementing and disseminating the training tools that TDR is developing within its expanding portfolio. Skill building and Train the Trainer (TtT) courses on effective project planning and evaluation (EPPE), Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) are now available in the four RTCs, and some courses have been integrated in university curricula. In June 2015, the RTCs developed GCP/GCLP TtT courses to be piloted and implemented in early These will be face to face courses with relevant clinical and laboratory site visits. The plan is to work with the Karolinska Institutet to accredit the courses. In line with that, online refresher courses for trainers will be developed in The RTCs have also disseminated the training courses in different national universities and, through a network covering South and Central America (Bolivia, Costa Rica, Ecuador, El Salvador, Guatemala, Honduras and recently Suriname), the Western Pacific and South East Asia (Viet Nam, Cambodia and Laos) and Central Asian States (Kyrgyzstan, Tajikistan, Uzbekistan, as well as Azerbaijan). To broaden the scope of research covered by the GCP guidelines (namely ethics and quality), the RTC network has collaborated with the London School of Hygiene and Tropical Medicine (LSHTM) and the Secretariat of the WHO Ethics Review Committee to develop a training programme on Good Health Research Practice (GHRP). This adapts the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) CGP guidelines to a wide range of health research, including implementation research, with a focus on resource poor countries. In 2015 this training course was finalized in Kazakhstan. Training materials are now ready to be used by all the RTCs in the biennium. Short term training (IMPACT) grants The short term training (IMPACT) grants scheme was established in 2013 with the aim of optimizing Interventions, Methods, Policies, Actions, Campaigns or Tools for improved health and well being of those burdened by malaria, tuberculosis and neglected tropical diseases (NTDs). The goal is to acquire research skills and competence to improve disease control and use results effectively. The key criterion for awarding an IMPACT grant is that the activity must lead to strengthened research capacity and promote the sustainable uptake, adoption, and/or implementation of evidence based interventions.

14 14 Page RCS/KM Annual Report 2015 The focus in 2015 was to increase capacity to undertake implementation research and contribute more effectively to disease control in collaboration with disease control programmes. An evaluation of the scheme will help inform the format and focus in the next biennium. In the third round of the scheme (2015), TDR received 125 applications from 42 LMICs. The regional distribution was 70% from AFRO (88); 8% (10) from EMRO; 8.8% (11) from AMRO/PAHO; 8.8% (11) from SEARO; 1.6% (2) from WPRO; and 2.4% (3) from EUR. Those applications which did not meet the basic eligibility criteria were screened out, leaving 61 applications. After internal TDR review, 50 applications were shortlisted for external expert review. After consideration of reviewers comments and the panel discussion, the SWG recommended 43 of these for funding (Table 2). The gender distribution (women/men) was 36%/64% among applicants and 37%/63% among those recommended for funding. The grants were awarded to investigators from 23 LMICs. Table 2. Short term training (IMPACT) grants 2015 No Last name Gender Country Project Title 1 Akogbeto Man Benin Expanding the evaluation of disease data management system in Benin 2 Sequeira Man Brazil Capacity strengthening in antimalarial efficacy monitoring and differential management of acute febrile illnesses: fostering a Brazil Thailand collaboration 3 Badolo Man Burkina Faso Dengue in Burkina Faso: establishing a vector biology evidence base for risk assessment and vector control strategies for an emerging disease 4 Takougang Man Cameroon Capacity building for implementation research in disease control programmes in Cameroon 5 Tepongning Man Cameroon Fight against the accumulation of health, environmental vulnerabilities, territorial and socio economic: the case of dengue and chikungunya: GIS and statistical inputs to the analysis of data 6 Etang Woman Cameroon Strengthening ethics and bioethics capacity for investigators health research in Central Africa 7 Okoko Woman Cameroon Operational research training for human African Trypanosomiasis programme coordinators in Central Africa 8 Verlez Bernal Man Colombia Training on health informatics tools for knowledge management purposes applied to control and treatment of neglected tropical diseases 9 Daka Man Ethiopia Training on evaluation researches: process, outcome and impact evaluation for program improvement, accountability and knowledge generation. 10 Tsefaye Man Ethiopia Effective implementation research skill training for the prevention, control and elimination of malaria, TB and NTDs. 11 Wossen Woman Ethiopia Strengthening capacity of stakeholders in implementation research and knowledge management in Jimma zone, Ethiopia 12 Afrane Man Ghana Predicting and validating the consequences of insecticide resistance on malaria transmission

15 RCS/KM Annual Report 2015 Page 15 No Last name Gender Country Project Title 13 Massavon Man Ghana Short term training grants for research capacity strengthening and knowledge management 14 Dayo Gyeke Woman Ghana Research skills capacity building for community health officers in Ghana 15 Owusu Woman Ghana Knowledge transfer from one generation of experts, to the next generation of young researchers: short term training work shop in writing and publishing review and original articles 16 Espinoza Woman Honduras Establishment of the network of research ethics committees (REDCEIH) and strengthening of ethical research in Honduras 17 N Guessan Man Côte d Ivoire Intensive training in epidemiology, statistics and informatics and intensive course in multivariate analysis applied in epidemiology 18 Duisenova Woman Kazakhstan Implementation research training using Echinococcosis as a model in Kazakhstan 19 Deya Woman Kenya Impact of active case finding interventions on tuberculosis control 20 Ochodo Woman Kenya Implementation strategies for guidelines to increase case detection of TB by healthcare workers: a systematic review 21 Sitima Man Malawi Analysis of village level onchocerciasis coverage data from Malawi: support policy making on NTD control and build research skills 22 Gaye Man Mauritania International course in epidemiology, biostatistics and qualitative research methods 23 Adhikari Man Nepal Operational research capacity strengthening of local health system and civil society towards malaria elimination in Nepal 24 Adeyemi Man Nigeria Attachment with Harvard Implementation Science Research Group Boston, USA on statistical methods for implementation science research & a systematic review and pooled analysis of insecticide treated nets for malaria prevention among pregnant women and under five children in sub Saharan Africa. 25 Avong Man Nigeria Improving the quality of adverse drug reaction reports in Nigeria through structured training program 26 Mogaji Man Nigeria Attachment and mentorship at the department of public health and disease control, Ogun State Ministry of Health, Nigeria 27 Oduola Man Nigeria Assessing outcome of capacity building interventions on malaria vector control programs in selected Nigerian institutions 28 Oladepo Man Nigeria IR training for young investigators in health related disciplines in SW Nigeria 29 Uneke Man Nigeria Improving researchers and policymakers capacity for implementation research for the control of infectious diseases of poverty in Nigeria using a two way secondment model between the university and health ministry 30 Akinwale Woman Nigeria Building lab diagnostic capacity and strengthening existing lab system for Buruli ulcer control and research in Nigeria

16 16 Page RCS/KM Annual Report 2015 No Last name Gender Country Project Title 31 Anumudu Woman Nigeria Acquisition of operational research skills for schistosomiasis geovisual analytical surveillance in Kisumu, Kenya for the development of an intervention for schistosomiasis control in Nigeria 32 Perveen Woman Pakistan Strengthening capacity of students, health managers and researchers to identify and address implementation challenges during the deployment of disease control programs in Pakistan 33 Razia Woman Pakistan Short term training grants for research capacity strengthening and knowledge management 34 Magatte Man Senegal Strengthen junior African scientist research capacity on antimalarial resistance markers in field isolates 35 Asugeni Woman Solomon Islands Strengthening operational research for communicable disease control in East Kwaio, Solomon Islands 36 Kabil Man Somaliland Knowledge management short term training of researchers in Somaliland. 37 Agampodi Man Sri Lanka Implementation research training for control of tropical diseases in Sri Lanka 38 Kusumawathie Woman Sri Lanka Skill development of preventive health staff on implementation research and management of knowledge for effective dengue control in Sri Lanka 39 Sulaimon Woman Sudan Competence enhancement of postgraduate candidates for vigilant implementation research in Sudan 40 Bakuza Man Tanzania Using geospatial data to enhance the control of schistosomiasis and soil transmitted helminthiasis in Southern Tanzania 41 Managwa Man Tanzania Training on population genetics data analysis of g. Pallidipes for decision support on hat control in Tanzania 42 Bui Man Viet Nam Capacity building for implementation research in TB in Viet Nam (CAR TB) TDR Career Development Fellowship (CDF) programme The TDR Career Development Fellowship programme started in 1999 and was scaled up in 2008 and 2014 with the support of the Bill & Melinda Gates Foundation (Gates Foundation) in collaboration with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The objective of the programme is to contribute to enhancing the capacity of individuals and institutions in LMICs to undertake and manage clinical research that meets international standards of regulatory requirements for the development of new diagnostics, drugs and vaccines for infectious diseases of poverty. By August 2014, a total of 42 fellows from 24 LMICs have been trained in 18 European and North American partner organizations. On completion of their fellowship, individuals are expected to return to their home institution to assume a DEC leadership role and become valuable resources in the global effort on R&D for IDPs. Within the existing programme, all fellows except one who have returned home have assumed pivotal roles in a wide range of R&D projects, including trials for new candidate vaccines and drugs.

17 RCS/KM Annual Report 2015 Page 17 In 2013, a training fellowship programme, managed by the European & Developing Countries Clinical Trials Partnership (EDCTP), was proposed to place LMIC scientists and clinical staff in pharmaceutical companies and product development organizations for hands on experience of clinical product development processes for diseases of poverty. Within its capacity building efforts, EDCTP is collaborating with the European Federation of Pharmaceutical Industries and Associations (EFPIA) to develop a fellowship scheme for clinical staff and researchers which offers placements in Europebased companies which conduct trials to the highest international standards. Since members of IFPMA and EFPIA overlap, EDCTP and TDR have addressed the potential for competition between their fellowship schemes, even though the scheme developed by EDCTP was not yet implemented. Considering their many similarities in terms of training areas, potential fellows and pharmaceutical firms identified as partners, EDCTP and TDR signed an agreement in March 2014 to harmonize and streamline their activities for mutual benefit. This partnership allows the development of a common vision and understanding of both fellowship programmes goals and objectives, with strong potential to enhance the capacity of each. Furthermore, the increased number of scientists and clinical staff trained will have a bigger impact on R&D capacity in LMICs while avoiding duplication of efforts. Results of the first EDCTP TDR joint selection Both partners issued a single EDCTP TDR call for applications (deadline 30 January 2015) with a joint review and selection process, but developed two inter related training programmes with distinct administrative processes and budget management. Twenty host organizations agreed to participate in the first round of selection of the fellows. The call attracted 109 eligible applications from 33 countries. A Scientific Review Committee meeting took place on April 2015 at TDR. The applications, scores and reviews (three per application) were discussed in depth at the meeting. As a result, 41 candidates were shortlisted for interviews by the host institutions in the presence of EDCTP and/or TDR. Interviews took place in June and July The host organizations selected 23 applications. Twenty one fellows are coming from the WHO region for Africa (9 countries including Burkina Faso (5); Ethiopia (5); Ghana (2), Kenya (2); Mali (2); Nigeria (1); South Africa (2); Tanzania(1) and Zimbabwe (1). One fellow is coming from the Eastern Mediterranean Region (Tunisia) and one from the South East Asian Region (Nepal). TDR supports 18 fellows and EDCTP five. The 13 host partners are located in the following countries: USA (Astellas), Belgium (GSK Biologicals), Germany (European Vaccine Initiative (EVI), Bayer and Merck), Italy (GSK Sienna), Luxembourg (Institute of Health), Switzerland (FIND and Novartis AG), UK (GSK and Worldwide Antimalarial Resistance Network (WWARN)) and South Korea (International Vaccine Institute (IVI)). AERAS has location in USA and South Africa. Six among them are new host partners (EVI, Bayer, Merck, WWARN, IVI and AERAS).

18 18 Page RCS/KM Annual Report 2015 Second EDCTP TDR joint selection A second joint call for applications was launched on 30 October 2015 with a deadline of 22 January Nineteen organizations agreed to participate in the second round. Companies/organizations City, country Number of places Aeras Cape Town, South Africa 2 Astellas Deerfield, USA 1 Bayer HealthCare Pharmaceuticals Berlin, Germany 3 Centre for Tropical Medicine and Global health (WWARN Group) Oxford, UK 2 European vaccine Institute (EVI) Heidelberg, Germany 1 Foundation for Innovative New Diagnostics (FIND) Geneva, Switzerland 2 GSK Biologicals Wavre, Belgium 1 Infectious Disease Research Institute, Seattle, USA 3 International Vaccine Institute (IVI) Seoul, South Korea 1 Janseen Global Public Health Beerse, Belgium 1 Julius Clinical Zeist, The Netherlands 2 Luxembourg Institute of Health Luxembourg, Luxembourg 2 Merck Serono Geneva, Switzerland 1 Medicines for Malaria Venture (MMV) Geneva, Switzerland 2 Novartis Institutes for BioMedical Research (NIBR) Basel, Switzerland 1 Novartis Pharma AG Basel, Switzerland 2 Sanofi Pasteur Mexico City, Mexico 1 A Scientific Review Committee meeting will take place in TDR, Geneva in April The outcome of the selection is expected to be available at the end of June 2016 and fellows will be placed at host partners in the last quarter of 2016.

19 RCS/KM Annual Report 2015 Page 19 CDF network All CDF Fellows are enrolled in a professional membership scheme (PMS) through The Global Health Network 1. This network is part of an online continuing professional development scheme for clinical trialists working in global health, and is supported by the Gates Foundation. The aim is to address the lack of recognition of clinical research as a profession and to encourage career development and training opportunities for all types and levels of researchers and clinical research staff. The PMS is available via the Global Health Trials website 2. Users post profiles through which their development and skills acquisition are measured and tracked to capture advancement throughout their career. Developing a framework for core competencies in clinical research Training programmes on research in clinical and product development often focus on investigators and ethics committee members. Training of other stakeholders (e.g. management teams, clinical monitors, and regulatory authorities, medical and allied students) is often neglected. There is also at present lack of recognition of research as a career which contributes to low research output and capacities in many LMICs. TDR proposed to map different roles within clinical research teams and the skills needed by each person in their specific role. To this end, TDR commissioned the Global Health Network (Oxford, UK) to document the full set of competencies for clinical research professionals to bridge the lack of information about research roles performed in LMIC settings and to provide a means for assessing gaps in training for research staff. The Workshop to Develop a Global Core Competency Framework for Clinical Research meeting was held in WHO, Geneva on September 2015, with the aim of reviewing a draft Global Core Competency Framework for clinical research developed by The Global Health Network and TDR, and of developing a strategy for validation and implementation of this framework in practice. Thirtyeight experts representing 24 organizations participated. The validated framework developed at the workshop will include a pilot phase to assess its usefulness and applicability in the given settings. Implementation research In 2014, TDR launched a toolkit to help strengthen capacity to conduct implementation research (IR) embedded in disease control programmes. The IR Toolkit is a tutorial to be used in modular group learning/workshop programmes. It is designed to help a broad range of stakeholders such as researchers, policy makers and disease control programme officers to identify system bottlenecks, formulate appropriate research questions and conduct research to address the bottlenecks. It covers the skill sets that may be required in IR including health system dissemination / communication, and uptake of results. It is available in print and downloadable pdf files as a participant manual with slides, and a facilitator s guide on the TDR website. Following the publication and availability of the IR Toolkit, TDR began to receive requests from institutions and research teams in LMICs for support to use the toolkit. In addition, several new short term training (IMPACT) grant projects were designed to apply the concepts in the toolkit. A core team of facilitators who were part of the development team have helped research teams in Ghana, India, Swaziland and the United Republic of Tanzania develop implementation research projects using the toolkit. 1 2 https://globalhealthtrials.tghn.org/cpd/about/

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