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Second phase of clinical trials partnership launched

A second phase of the European and Developing Countries Clinical Trials Partnership (EDCTP2) was launched in South Africa on 2 December.

For the first time 11 African countries will govern the EDCTP and contribute funds to the initiative.

Deborah-Fay Ndlovu speaks to Michael Makanga, the director of South-South Cooperation and head of the EDCTP Africa office, about its future and how the partnership convinced African countries to invest.

What is EDCTP and why was it set up?

The EDCTP was created by the European Union in 2003 to tackle poverty-related diseases—HIV/AIDS, tuberculosis and malaria.

It provides grants to develop new or improved interventions for the poverty-related diseases and tests them in clinical trials. It also gives fellowships to masters, PhD, postdoctoral and to junior, mid-career and senior scientists in sub-Saharan Africa to develop their careers.

It funds initiatives to build the ethics and regulatory capacity of sub-Saharan African countries. This is to ensure that scientists conduct quality clinical research.

You have launched a second phase of the programme. How is it different from the first phase?

For starters, the funding is more that that of the first phase. The EU contributed €200 m (US$245m) in the first phase with member countries giving matching funds. The EU is providing €683m for this phase. The European countries involved in the partnership will match the EU contribution with an additional €683m.

We hope to leverage an additional €500m from the private sector and philanthropic organisations.

The EDCTP has also widened its remit in the second phase to include neglected tropical diseases and emerging infectious diseases. It will also fund phase one and four clinical trials in addition to the phase two and three trials for drugs, vaccines and diagnostic tools for HIV, tuberculosis and malaria covered in EDCTP1.

The partnership is now an international association, which enables African countries to become member states. This means they can vote in the EDCTP General Assembly, the partnership’s supreme decision-making body.

African countries are reticent to fund research but 11 have committed to contribute funding to the EDCTP. How did this happen?

We held a high level meeting in South Africa in 2012 where we invited governments and other funders. After that meeting we wrote to the governments explaining about the EDCTP and how they could become members.

We followed that up with another high-level meeting in Senegal in October 2013 where we specifically addressed African participation and contribution to the programme. The governance and legal structure had to change when we opened up membership to African countries.

The new statutes allow African countries to share the association’s responsibilities and to vote. So far 11 African countries—Cameroon, the Republic of the Congo, The Gambia, Ghana, Mozambique, Niger, Senegal, South Africa, Tanzania, Uganda and Zambia—have joined.

Burkina Faso, Gabon and Mali have applied to become members.

What have been some of the achievements of the EDCTP?

The programme funded 254 projects with 72 per cent of those being led by African researchers. Some of the 500 scientific and policy reports and the data we produce have been used by the World Health Organization to develop management and prevention guidelines.

It also collaborated with WHO to create the Pan African Clinical Trials Registry, a WHO accredited primary register of trials conducted in Africa. It has helped to develop research infrastructure and train African scientists. It has promoted intra-Africa collaboration and that between European and African scientists.

What challenges have you faced in implementing the partnership? How did you overcome them?

This is the very first instrument of the EU that involved the coordination of European investment in research. It involved talking to and actively engaging with multiple partners, especially governments, and publicly funded research and development national programme, to get them to agree to work on common principles and a centralised process.

Our grantees were required to provide co-funding. This co-funding was initially on a project by project basis but grantees found it difficult to talk to governments for additional funding. We have changed the rules so that co-funding is matched on a programme basis.

The majority of your projects were African-led. Were you not concerned, like most donors, that institutions would not have the capacity to manage the grants?

When we support projects we also provide funding to mentor and develop science leaders who can strengthen their institutions’ systems to manage our grants. In addition we fund project management and financial administration.

How did this benefit the African countries?

The 72 per cent figure was a progressive increase. It didn’t start out like this but we encouraged training and mentorship. By supporting leadership development we now have scientists who are competent to run larger research projects funded by various other donors.

Even though this is a step in the positive direction, Africa still needs to scale up funding for research.