With this article, we hope to feed the reflection on the methodological and ethical aspects of clinical trials carried out in developing countries by North-South collaborative research groups. Our reflection and suggestions come from the concrete experience of a non-commercial multi-center trial (A Head-to-Head Comparison of Four Artemisinin-Based Combinations for Treating Uncomplicated Malaria in African Children: A Randomized Trial. PloS Medicine 2011). In particular, we would like to encourage North-South collaborative research groups to join forces for jointly developing context-adapted tools, e.g. in the field of  clinical data management and of monitoring, as well as for sharing in a public space some key-information. We also want to stress the need for an update of the current WHO Good Clinical Practices Guidelines, which were issued in 1995 and do not always take into account the challenges met in North-South collaborative clinical research.

 

The text is available via the PDF on the right hand side of the page, or through the link below: http://onlinelibrary.wiley.com/doi/10.1111/tmi.12036/pdf

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