THERAPY

Aiding or exploiting Africa?

Youths chat concerning life, painting by George Lilanga (2000). © George Llilanga Courtesy C.A.A.C. – The Pigozzi Collection, Geneva
Youths chat concerning life, painting by George Lilanga (2000). © George Llilanga Courtesy C.A.A.C. – The Pigozzi Collection, Geneva

As the continent hardest hit by fatal diseases, Africa offers enormous potential for clinical trials but rarely benefits from the results. Europewants to reverse this trend.

Malaria, AIDS and tuberculosis are ravaging the world's poorest countries. Killing nearly 6 million people a year, these diseases are devastating sub-Saharan Africa, by far the world's worst-affected region. The region accounts for 90% of all malaria-associated deaths and 90% of its children are HIV-positive.

Every year, a million new cases of tuberculosis are reported in sub-Saharan Africa.

It was to counter these dire statistics that the European and Developing Countries Clinical Trials Partnership (EDCTP) was created in 2003. "Some pharmaceutical companies do not view the search for AIDS, malaria and tuberculosis treatments as ‘sexy' because the hardest-hit populations are very poor and represent a less attractive investment," explains EDCTP Executive Director Charles Mgone. Born in Tanzania, Mgone is a paediatrician specialising in molecular genetics. The programme focuses chiefly on the trickiest phase of pharmaceutical research, the clinical trial, which can account for as much as 40% of the cost of developing a new treatment. "We try to optimise the use of public resources allocated to these diseases by including in the same clinical trial several teams involved in similar research areas," he says.

Consultation

The EDCTP's regular calls for projects are genuine partnerships. "The Developing Countries Coordinating Committee (DCCC) identifies local requirements, while the European Network of National Programmes (ENNP) pinpoints research programmes financed by EU Member States that could be grouped into a single clinical trial. We are firmly opposed to the sort of paternalism that characterises some North-South collaboration initiatives. The calls for projects are developed after lengthy consultation, and all the projects include teams from both continents."( 1) This approach aims to suit therapies to local conditions. It was an EDCTP trial that led to the marketing of the antiretroviral therapy Triomune, which was formulated bearing in mind the large proportion of HIV-positive children living in sub-Saharan Africa. Notably, the tablets are soluble and easy to break in small pieces.

The EDCTP 's work does not stop at clinical tests. The programme also aims to build local capacity, as increasing numbers of pharmaceutical companies are turning to Africa for their clinical trials in a bid to cut costs by 10%-50%. "We earmark funding for setting up and training local supervisory teams. Where necessary, we also train the ethics committee members responsible for examining the protocols and giving the goahead for clinical trials." This is critical because in the developing world the authorities that issue permits for clinical tests are reputed to be less exacting. This makes the risk of abuse very real...

Julie Van Rossom

  1. All quotes are from Charles Mgone.


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From molecule to treatment

A clinical trial consists of four phases:

Phase I. Involving a small group of healthy ndividuals (20-80). Objective: to confirm the molecule's safety and detect any side effects.

Phase II. Involving a larger group of patients 20-300). Objective: to gauge the molecule's efficacy nd determine methods of administration.

Phase III. Involving a large number of atients (300-3000+). This is a comparative study to evaluate the effect of the new molecule ith a placebo or a reference treatment. If this phase is successful, an application for marketing uthorisation may be submitted.

Phase IV. Study of the long-term side ffects after the molecule has been placed on the market.


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  • European and Developing CountriesClinical Trials Partnership (EDCTP)
    16 European countries (AT, BE, CH, DE, DK,ES, FR, GR, IE, IT, LU, NL, NO, PT, SE, UK)
    45 African countries (AO, BF, BI, BJ, BW, CD,CF, CI, CM, CO, CV, ER, ET, GQ, GA, GM, GH,GW, KE, KM, LS, LR, MG, ML, MR, MU, MW,MZ, NA, NE, NG, RW, ST, SN, SC, SO, SD, SZ,TD, TG, TZ, UG, ZA, ZM, ZW).
    www.edctp.org