title: Reflections on clinical research in sub-Saharan Africa.
abstract: The urgent need for new, safe and sustainable interventions against diseases that disproportionally affect the poor is finally receiving global attention and the funding landscape for development projects has significantly improved during the past decade. For the development of new drug and vaccine candidates, clinical trials have become the most important tool to assess their safety and efficacy. Recently, there has been a seismic shift in the number of clinical trials conducted in resource-limited settings. We discuss the current framework of clinical research in sub-Saharan Africa, from building product pipelines to the capacities needed for the conduct of trials according the harmonised Good Clinical Practice (GCP) ICH E6 guideline. We place emphasis on clinical research in neglected tropical diseases which still frequently has to be conducted with limited financial, logistical and human resources. Given those short-comings we recommend minimum standards needed at the local, national and sponsor levels to provide GCP-compliant clinical research.
authors.affiliation: Swiss Tropical Institute, Pharmaceutical Medicine Unit, Basel, Switzerland. irene.kuepfer@unibas.ch
authors.forename: Irene
authors.initials: I
authors.lastname: Kuepfer
authors.forename: Christian
authors.initials: C
authors.lastname: Burri