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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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.
Ken Awuondo, Clinical Trials Laboratory Manager for the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya gives an overview of the role of the laboratory in clinical trials. In clinical trials, laboratory tests are used to establish inclusion and exclusion criteria, determine baseline parameters, monitor the safety of the participants and demonstrate the efficacy of the investigational product. The talk wraps up by discussing some of the challenges facing labs in clinical trials.
Clinical Trials in Resource-Limited Settings
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.
