New clinical trials initiative steps closer

Crawling towards the Nirvana of effective new drugs and vaccines for the big African killers — HIV/AIDS, TB and malaria — the European Commission has taken another important step towards establishing a cooperative international programme to solve a major practical problem in developing new products for Africa: how to do clinical trials in the region.Last month the EC announced that Commissioners — the top bureaucrats — have approved what is potentially a $600 million, four-year programme, the European and Developing Countries Clinical Trials Partnership (EDCTP). It took three years of gestation, and a final positive meeting with the Director General of the World Health Organization, Gro Harlem Brundtland. Although aimed at all developing countries, at the outset it will focus on Africa.Antoni Trilla of the University of Barcelona, the Coordinator of the EDCTP, and his colleagues, are still working to define exactly what the partnership will do. Its objectives, according to Trilla are:• To support the networking and pooling of trials within the EU (largely Phase I trials), including the infrastructures needed to support these trials; • To support the networking and pooling of trials activities in developing countries;• To support the development of trials infrastructures in developing countries, with a focus on capacity-building and training;• To sponsor new clinical trials, by putting together financial packages that attract external sources of co-financing, particularly in partnership with the European biopharmaceutical industry;• To develop a European, rather than national, presence in international initiatives for research and development covering the three diseases.But the new initiative is not finalized yet. The next hurdles will be approval by the European Parliament in October, and then by the final political governing body of the 14-state European Union, the Council of Ministers, plus one outside partner: Norway. This is expected "early next year."According to Marie-Paule Kieny, director of the WHO Initiative for Vaccine Research, "We've had several meetings with the EDCTP but everything at the EU goes so slowly." Nevertheless the programme will be welcome. "There are clinical trial sites in Africa for testing for each of the three diseases, but they are scattered, the resources are not enough and the networking is poor" says Kieny. "And the EDCTP has impressive funding."But only one third of the funding will come from the Commission itself, and the source of the other US$400 million is somewhat hazy. US$200 million is to come from member states, but there is no guarantee they will cough up — and if they do, whether it will be new money. The remaining US$200 million is hoped to come from industry or other partners.José Esparza, who has been responsible for HIV/AIDS vaccinology at WHO but now deals with all viral vaccines, has also been involved with the partnership. "At the beginning the idea was very European" — coordinating European trials programmes — and WHO and African partners had to press harder for "a meaningful participation" of developing countries in the programme. "But I think they are going in that direction." Antoni Trilla confirms that while the governance structure will involve a Steering Committee with two representatives from each European Union country, there will also be a Working Group with 15 Europeans and 15 Africans, a Management Group with five Europeans and five Africans and a Coordination Team consisting of one African and one European.But no doubt driving despair into the heart of the EU, Esparza believes yet more coordination is required: "The EDCTP can only succeed if they coordinate with other efforts. The last thing we want to see is Americans and Europeans and others fighting for sites in Africa… But it's a good initiative and we are strongly supporting it."What is really needed, according to WHO experts, is to develop and coordinate African trial sites. Such a site would have a population with the appropriate epidemiology of the disease being studied. "Then you need scientific infrastructure, political support and community support in the region. Those four things will make a working trial site," said Esparza.The concept of a 'site' is "something that is evolving" says Esparza. "In the past a site was where foreign investigators could come to a country and do research to take their samples back home and publish a paper. That concept has gone. The sites we're talking about, that EDCTP wants to develop, are ones with ownership in the country, as that's the only way to ensure continuity, and the appropriate investment of time and resources."Marie-Paule Kieny also argues that Africa needs to build the capability to do 'on-site' some of the immunological testing, "…which is still often done in Europe or the US." Kieney would like to see the EDCTP support the networking of existing and new facilities. "For example the International AIDS Vaccine Initiative [IAVI] is investing in Kenya and Uganda to do very complex immunological analysis. This kind of capacity could be used for more than one disease. So I'd like to investigate networking these. EDCTP should be helping us with that."

New clinical trials initiative steps closer

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