European Union Launches African Clinical Trials Program

By Mark Boaz

On 27 March 2003, the European Parliament endorsed the creation of an Africa-based clinical trials program to test new medical products targeting AIDS, malaria and tuberculosis.

The endorsement came with €€200 million in direct funding from the “Sixth Framework Programme,” the European Union’s (EU) research strategic plan for 2002-2006, and an expectation that another €400 million will be contributed over this timeframe through in-kind support from national programs and additional donations from industry, member state governments, multilateral agencies and other sources.

 

Pending final approval by the European Council on 12-13 May, the program will be launched as an entity independent of the European Commission (EC), with its own scientific planning board plus a fundraising and administrative body.

The European and Developing Countries Clinical Trials Partnership (EDCTP) will support Phase II/III clinical studies of both therapeutic and preventive interventions (including drugs, vaccines and microbicides), according to Arnd Hoeveler, Head of the EC’s Poverty-Related Diseases Unit that coordinated the program’s planning. The research agenda will be set once a Partnership Board is established, and will be organized around several core objectives: Building laboratory and human capacity in developing countries; fostering both North-South collaborations and South-South networking; facilitating better integration of European national programs; and development of locally relevant and affordable interventions for the developing countries. Much of the EDCTP’s activity will build on sites and projects already supported through bilateral programs between single European and African countries, although the current plan states that groups from any country can participate. While the Sixth Framework Programme’s activities on poverty-related diseases require at least two European and two African partners, it remains to be decided whether the Partnership Board will extend this requirement to the EDCTP.

The Partnership Board will consist of 12 researchers—four selected by an African strategy committee (see box) that is already at work, four by the European states, and four more by the initial eight members, according to Dagmar Baroke of Germany’s Ministry for Research and Technology, who is involved in planning the EDCTP. Two representatives of the EC will also sit on the Board but will not have voting rights. Spending and administrative authority will rest with a separate group consisting of members from the member states’ national research agencies, and which will establish one Secretariat in the Hague and another at an African location still to be decided.

Recruitment for an Executive Director of the EDCTP is underway, with advertisements for this position and also those for Board members placed in the press. Planners anticipate a call for research proposals by September, and expect the first projects to be chosen in late 2003. Although no official numbers are yet available, sources say that about €30 million will be committed by year’s end.

The EDCTP’s Developing Country Coordinating Committee Members of this group were chosen to represent four regions of Africa (sub-Saharan, East, Central and West) and the three diseases that fall under the EDCTP. The members are: For HIV/AIDS: Simon Agwale (Nigeria), Kobus Herbst (South Africa), Anatoli Kamali (Uganda) and Lynn Zijenah (Zimbabwe) For tuberculosis: Kashongwe Munugolo (DRC), Joseph Odhiambo (Kenya), Voahangy Rasolofo (Madagascar) and Oumou Sow (Guinea) For malaria: Dicky Akanmori (Ghana; committee chair), Francine Ntoumi (Gabon; committee co-chair), Akin Sowunmi (Nigeria) and John Waitumbi (Kenya)

The EDCTP’s organization, and its independence from the EC, is based on a legal structure called a European Economic Interest Group (EEIG)—a structure that has been used for a broad range of other scientific and cultural activities supported by the EC, such as the Arte cultural channel on cable television. For the EDCTP it was adopted in order to circumvent the fact that EU research activities are funded in five-year blocks (within Framework Programmes, which set the scientific priorities), but that a mechanism was needed to allow EDCTP projects and funds to continue beyond this limited period. EEIGs can continue as long as they receive support—whether from subsequent EU Framework Programmes or from other sources.

So if the EDCTP receives new funding for the post-2006 period, it will be able to initiate new projects beyond that date, says Baroke. But a more immediate challenge, she adds, will be for the program’s administrative arm to nail down contributions beyond the EU’s direct €200 million allocation and the in-kind support from member nations.