An Introduction to Clinical Trials

George Warimwe from the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya presents an introduction to clinical trials aimed at trial site staff and anyone new to the field. Topics covered include: equipoise and hypothesis, protocol, trial design, comparative effectiveness, pharmacovigilance, ICH-GCP basics, informed consent, essential documents, databases and statistics.

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The goal of the Global Health Clinical Trials Programme is to promote and make easier the conduct of non-commercial clinical research across all diseases in resource-poor settings. We present a series of short lectures to provide an introduction to clinical trials and explore some of the challenges facing clinical trialists in resource-limited settings.