An individual patient data collaboration for malaria treatment

Article type
Authors
Adjuik M, Taylor W, Babiker A, Garner P
Abstract
Background: We require new antimalarial drugs against drug resistant strains, and ways to prevent resistance developing. Drugs derived from the Chinese Qinghaosu (artemisinin) are powerful new antimalarials, and researchers suggest they are administered with other antimalarial drugs to improve outcomes and reduce the chance of drug resistance developing to either component of the combination.

Method: The TDR Programme of the WHO, with malaria researchers, agreed on a common protocol to assess the efficacy and tolerability of combinations of artesunate with one of the first line drugs currently in use in the various African countries, which include The Gambia, Senegal, Gabon, Kenya, Uganda, Sao
Tome, Malawi, Burkina Faso, and C te d'Ivoire. Activities: With help from the MRC Trials Unit, London, a process was established with collaborators for individual patient data analysis. This built on an earlier IPD in severe malaria. A secretariat was established who developed a protocol and consulted with the researchers. The data is being channelled through TDR, who are co-ordinating the individual trials. A statistician, who had worked on the Vitamin A trials in Ghana, has received additional training and is responsible for the data analysis. Staff at the Liverpool School of Tropical Medicine and the MRC Trials Unit provides technical and training support for the analysis.

Conclusions: The presentation will outline how the collaborative process was established, and progress to date. It will concern practical details of setting up this kind of work.