Mapping research

Several projects aimed at getting extensive information on research partners, research policies and research (published as well as planned) which would be relevant to the strategy and workplans of EDCTP2. First, a desk review of research programmes in the EDCTP member countries was conducted by the EDCTP Executive Secretariat.

A bibliometric analysis of African and European research programmes, partnerships, activities and capacities was commissioned in 2012 in order to analyse the fields of HIV/AIDS, tuberculosis, malaria and neglected infectious diseases over the period 2003-2011. The report,

Bibliometric analysis: European and African research output within the scope of EDCTP2 2003-2011, was finalised in 2013 and included a supplementary analysis of intra-European research collaboration in each of the disease areas, an evaluation of the impact of EDCTP-funded research and an overview of leading sub-Saharan African researchers based on research outputs and citations. A second study commissioned under EDCTP-Plus mapped research in poverty-related and neglected infectious diseases in the European EDCTP member countries. The report Charting research: EDCTP Member State programmes and activities in the scope of EDCTP2 presents a summary overview of activities and programmes relevant to the scope of EDCTP2. It highlights available capacities such as research infrastructure and expertise.

In collaboration with RAND Europe and Baird’s CMC, EDCTP mapped sub-Saharan African health research activities and capacities and analysed how these relate to national funding commitments, health research policies and the mission of EDCTP. The report Africa mapping: Current state of health research on poverty-related and neglected infectious diseases in sub-Saharan Africa shows the significant regional differences in the health research of sub-Saharan (volume, development and funding). The report highlights the importance of political will in African governments to contribute financially to establishing an adequate and sustainable research environment in sub-Saharan Africa. Currently, clinical research in the majority of sub-Saharan Africa countries relies heavily on international funding. According to many of the respondents interviewed, the main challenges are increasing its funding and improving awareness of most policymakers of the benefits and importance of research.

Stakeholder meetings

EDCTP held a series of thematic stakeholder meetings in preparation for the second EDCTP programme. Meetings on neglected infectious diseases (The Hague), HIV/AIDS (Lisbon), malaria (Vienna), tuberculosis and EDCTP-Plus: mission accomplished other mycobacterial infections (Paris), as well as meetings on health research ethics review and regulatory affairs (Antwerp) and capacity development (Berlin) brought together experts from research institutions, policymaker and representatives of product development partnerships, pharmaceutical industry and international organisations.

These meetings aimed to identify and review the current research issues, interventions, products in development and key players in the field; ensure that EDCTP remains focused on the most pressing research needs and the most promising opportunities; identify priority areas for the current and future calls for proposals; identify interested and potential partners to collaborate; harness the efforts of EDCTP stakeholders in order to promote integration of national programmes of EDCTP European Participating States and strengthen the partnership with African researchers.

Evaluation of the first EDCTP programme

A comprehensive external evaluation of the first EDCTP programme was conducted by the external consultancy firm Technopolis group as part of the preparations for the second programme. The report Assessment of the performance and impact of the first programme of the European & Developing Countries Clinical Trials Partnership (September 2014) was published on the EDCTP website in February 2015.

Evaluation of EDCTP ethics grants programme

A comprehensive evaluation of the EDCTP grants programme for strengthening research ethics review in sub-Saharan Africa and all 75 EDCTP-funded ethics projects was also commissioned.

The evaluation focused on the three funding areas: the mapping of ethics review and clinical trial regulatory capacity in sub-Saharan Africa (MARC); establishing or strengthening of National Ethics Committees (NECs) and Institutional Review Boards (IRBs); and training (including the development of online training programmes) for research ethics review.

The MARC project, executed by the Council on Health Research for Development (COHRED), was deemed to be a great success. MARC mapped 166 IRBs in 34 African countries and developed professional social network and discussion functions on the MARC website.

The main purpose of the IRB and NEC-related projects was to give operational support for office infrastructure development, training, development of standard operating procedures and improved quality of protocol review. This funding helped the ethics committees which face considerable personnel, systems and infrastructural challenges. Online ethics training activities provided a good return on investment. The data also shows a high level of efficacy in NECs and

IRBs and supports the conclusion that ethics has made a solid entrance into research ethics in Africa. Limited human resources and limited local financial support remain a threat to their sustainability.

Extended support for PACTR

In preparation for the second EDCTP programme, EDCTP has provided more support to develop the Pan African Clinical Trials Registry (PACTR). It is the only WHO-endorsed primary registry in Africa and trial registration in the PACTR portal (www.pactr.org) meets the requirements of the International Committee of Medical Journal Editors (ICMJE) and feeds information to the WHO International Clinical Trials Registry Platform (ICTRP). The PACTR registry facilitates understanding of regional research patterns, enables the identification of research gaps for future studies, and facilitates the investigation of the scope, quality and funding patterns of African trials. There was exponential growth in clinical trials registration with PACTR during 2014 with 388 clinical trials registered by end of the year.

Preparing for laboratory accreditation

EDCTP supported the development of the laboratory capacity of the Regional Networks of Excellence (NoEs). Through a consultative process, the four NoEs (CANTAM, EACCR, TESA and WANETAM) selected 24 clinical research and public health laboratories actively involved in EDCTP funded clinical trials in 18 sub-Saharan African countries. The selected laboratories have been systematically developed towards future accreditation by international laboratory accreditation agencies. The initial assessment was based on frameworks established by the International Organisation for Standardisation (ISO) and the World Health Organisation-African Region (WHO-AFRO) stepwise Laboratory Quality Improvement Process (SLIPTA).

The next phase of this EDCTP initiative was executed by the African Society for Laboratory Medicine (Ethiopia) and Quintiles Africa (South Africa) in 2014. They performed on-site gap analysis on all 24 laboratories. They proceeded to work with these laboratories to develop each laboratory forward in the process towards accreditation through mentorship programmes, training schemes and internal quality assessments.

Raising private and public commitment to EDCTP

Strong foundations for future EDCTP collaboration with the private sector and Product Development Partnerships have been established. Key events such as the ‘Pharmaceutical Industry Workshop’ (2012, The Netherlands), the ‘Post-Registration Mdicinal Products Safety Monitoring in sub-Saharan Africa’ meeting (2012, South Africa), as well as individual meetings with stakeholders indicated opportunities and enthusiasm for mutually productive collaborations under EDCTP2.

In January 2013, EDCTP and the European Federation of Pharmaceutical Industries and Associations (EFPIA) signed a memorandum of understanding on a clinical research fellowship scheme that will give sub-Saharan African researchers the possibility to be placed in European-based pharmaceutical companies. This scheme was merged with the WHO-TDR Career Development Programme which offers similar fellowships (but with a broader geographical scope). In 2014, EDCTP and TDR launched the first Clinical Research and Development Fellowship call for proposals on 31 October 2014. This call will be launched annually in order to build the necessary capacity in this area in sub-Saharan Africa.

Additionally, EDCTP actively sought to promote a wider European membership of EDCTP2 in order to integrate further the European clinical research effort regarding poverty-related and neglected infectious diseases. Part of this ongoing dialogue to expand the European membership of EDCTP was the one-day meeting of representatives of EDCTP member countries and prospective partner countries in Copenhagen in 2012. Finland joined the EDCTP Association as a new member.

In Africa, three high-level meetings were held in Africa to raise additional public and private engagement and support to EDCTP activities. The first ‘High-Level Conference on the second EDCTP programme’ was held in Cape Town in November 2012. This meeting marked an

important step in the consultation of African and international stakeholders. The meeting provided a forum to discuss stakeholders’ needs and expectations of EDCTP2. The second ‘High-Level meeting on EDCTP2’ took place in Dakar, Senegal in October 2013. The meeting galvanised the preparation of active and direct involvement of African countries in the EDCTP programme and governance. The strong willingness of African countries to be represented on the EDCTP General Assembly became abundantly clear. The third high-level meeting, again in Cape Town, South Africa on 2 December 2014 celebrated the actual launch of EDCTP2 with 11 African and 13 European countries having already joined the governing EDCTP Association as members.

Financial Management training workshops

Five financial management training workshops were held under EDCTP-Plus. The meetings took place in Dakar, Senegal (2012 and 2013) for finance staff of EDCTP grantees in West and Central Africa, and in Johannesburg, South Africa (2012, 2013 and 2014) for finance staff of EDCTP grantees in Eastern and Southern Africa grantee.

Preparation of the EDCTP organisation

EDCTP expanded its staff in view of the second programme. In 2012, in order to further research collaboration among the participating European countries, EDCTP appointed a North-North Networking Manager and a North-North Networking Officer. The development of the grants management and other systems required an Information Technology Officer (2012) while the EDCTP Africa Office appointed an additional Project Officer (2013).

The Executive Secretariat successfully underwent a comprehensive ex-ante assessment on its systems, policies, procedures for its readiness to implement and execute the second programme.

EDCTP implemented a new grants management system ‘EDCTP grants’, based on CC Grant Tracker®, a system developed by the company CC Technologies in Glasgow, United Kingdom. The system was implemented in order to substantially reduce the administrative complexity of grant application, review of proposals as well as reporting by grantees on EDCTP-funded projects. The new system went live on 31 October 2014.

As part of the advocacy and information efforts to enhance the visibility of the EDCTP programme, EDCTP produced an application (app) for tablets. This app allows quick access to most EDCTP publications regarding its activities and the projects it funds. The EDCTP website was restructured and restyled.