Preparations for the start of the second EDCTP programme (EDCTP2) commenced in 2012, when funding was received from the European Union for a programme of activities. This EDCTP-Plus project aimed to establish a strong and reliable foundation for executing the EDCTP2 programme with a bolstered EU-Africa research partnership. The activities were funded under the European Framework Programme 7 through a Coordination and Support Action Grant (FP7-304786) and were completed in 2014. Moreover, EDCTP2 received overwhelming support from the European Union, as well as the European and African Participating States, which led to the official launch of the programme on 2 December 2014.

Achievements of the first EDCTP programme

Targeting HIV/AIDS, tuberculosis and malaria, EDCTP has funded clinical trials on treatment drugs, vaccines, microbicides and diagnostics. Through its funding instruments, it has contributed to the coordination and integration of national research programmes. Results from various trials have informed national and international policies such as the WHO policy on the prevention of mother-to-child transmission of HIV and the registration of a paediatric formulation of an antiretroviral product (Pedimune) in several African countries. Furthermore, since 2003, EDCTP provided professional training to 516 African scientists and medical doctors, including 56 Career and Senior Fellows as well as more than 414 Master’s and PhD students.

Overall, EDCTP represents a flagship programme for conducting sound multi-country clinical trials in sub-Saharan Africa, building a true partnership between Europe and Africa, and fostering African leadership in scientific research. Europe’s strong commitment to partnership is reflected in the fact that 74% of EDCTP funding was invested in activities implemented by African research institutions. Over 70% of all EDCTP-funded projects were led by African researchers.

The EDCTP programme also contributed to networking African research which resulted in the launch of four African Regional Networks of Excellence for clinical trials. Moreover, the ethics and regulatory environment has been improved by strengthening ethics review capacity and national regulatory authorities in many African countries. EDCTP was the main funder of the African initiative to establish the Pan African Clinical Trials Registry (PACTR), an official WHO Primary Clinical Trials Registry.

The second EDCTP programme

EDCTP2 will run over a ten-year period from 2014 to 2024 with a budget of €1.36 billion in commitments. The European Union will provide a contribution of up to €683 million, on condition this is equally matched by contributions from the European Participating States. Additional funding will be sought from third parties and African Participating States.

The second programme will support all stages of clinical trials, from phase I to IV on HIV/AIDS, tuberculosis, malaria and neglected infectious diseases including emerging disease of particular relevance to Africa such as Ebola virus disease, for new or improved medical interventions, as well as advanced testing and field validation of new diagnostic tools.

The activities supported under EDCTP2 include:

• Multicentre clinical trials that are conducted by research consortia involving both European and African research teams, with integrated capacity development and networking elements
• Capacity support activities that strengthen the enabling environment for conducting clinical trials and clinical research
• Fellowships that promote career development and scientific excellence of individual researchers as well as training and mentorship of research team members.

Extended international cooperation with public and private research and development partners globally, as well as other European Union initiatives including development assistance is promoted in all these activities.

EDCTP-Plus

The EDCTP-Plus project aimed to prepare for EDCTP2 which would have an increased budget, a broader scope covering all phases of clinical trials from phase I to IV, as well as health services optimisation research, and an expanded disease remit with the inclusion of neglected infectious diseases. Additionally, a comprehensive review and revision of governance, as well as operational policies and procedures was required to ensure EDCTP2 complies with the Horizon 2020 rules of participation. The project started in 2012 and the activities were completed in December 2014. The major achievements of the EDCTP-Plus project are summarised below.

Stakeholder meetings
Six thematic stakeholder meetings were held in 2013 and 2014:

• Neglected infectious diseases (The Hague, the Netherlands, 27-28 June 2013)
• HIV/AIDS (Lisbon, Portugal, 3-4 September 2013)
• Malaria (Vienna, Austria, 19-20 September 2013)
• Tuberculosis and other mycobacterial infections (Paris, France, 28-29 October 2013)
• Health research ethics review and regulatory affairs (Antwerp, Belgium, 28-29 November 2013)
• Capacity development (Berlin, Germany, 3 July 2014).

The aim of the meetings was to highlight gaps, opportunities and barriers to progress, identify potential partners for joint initiatives, and to engage and inform stakeholders of the achievements of the first EDCTP programme, as well as the lessons learned. These meetings brought together experts from research institutions, policymaker and representatives of product development partnerships, pharmaceutical industry and international organisations. The recommendations of the stakeholder meetings have contributed towards the strategies and operation business plans of EDCTP2. The reports of these meetings are available on the EDCTP website (www.edctp.org).

Mapping research
Improving coordination and cooperation among the participating European States and enhanced engagement with the private sector and like-minded organisations are EDCTP2 objectives. The published report Charting Research – EDCTP Participating States programmes and activities in the scope of EDCTP2 and a draft report on mapping the research programmes and relevant research cooperation activities in the newest EU Member States have informed the EDCTP2 Participating States and the Secretariat on areas of mutual interest and facilitated the submission of Participating State Initiated Activities (PSIAs) in the annual work plans.

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.

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, published in September 2014, shows the significant regional differences in the state of health research in sub-Saharan in terms of volume, development and funding levels.

Investing in research capacity
The EDCTP-Plus project explored the consolidation and enhancement of some of the achievements of the first EDCTP programme such as optimal utilisation and retention of the invested capacity. Development of 24 laboratories – six per EDCTP Network of Excellence (CANTAM, EACCR, TESA and WANETAM) – through the Stepwise Laboratory Improvement Process Toward Accreditation (SLIPTA) was undertaken. The Pan African Clinical Trials Registry expanded the scope of trials it registers, enhanced the features and functionality of its website, and raised awareness of trial registration in Africa through advocacy and engagement with national registries. These activities may partly explain the major rise in applications for registration over the course of this project. Five finance management training workshops were held 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.

Preparation of the EDCTP organisation
In view of the second programme, EDCTP has improved its operational activities to ensure compliance with the Horizon 2020 rules for participation. This brought the successful implementation of a web-based grants management and online application system (EDCTPgrants); preparation of comprehensive and more structured financial guidelines for grant-holders; improvement of IT infrastructure capability, including IT administrative systems at the EDCTP Secretariat; and revision of policies, procedures and manuals in readiness for EDCTP2. Moreover, a comprehensive external evaluation of the first EDCTP programme was conducted by an external consultancy firm, Technopolis Group. The findings of the report Assessment of the performance and impact of the first programme of the European & Developing Countries Clinical Trials Partnership (September 2014) are available on the EDCTP website.

Raising private and public commitment to EDCTP
Strong foundations for future EDCTP collaboration with the private sector and product development partnerships have been and continue to be established. Key events were the ‘Pharmaceutical Industry Workshop’ (2012, The Netherlands), the ‘Post-Registration Medicinal 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.