Clinical Trials in Resource-Limited Settings

Dr Simon Ndirangu, Bioanalytical Laboratory at the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya describes the basic concepts of pharmacological clinical trials, pharmacokinetics and pharmacodynamics. The talk goes on to discuss the various methods used and costs involved as well and other important factors to consider as well as addressing some of the challenges faced in Measuring Drug Levels in Clinical Trials.

Dr Simon Ndirangu, Bioanalytical Laboratory at the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya discusses the importance of implementing occupational health and safety standards in research settings. Effective occupational health and safety programmes reduce work related injuries and illnesses, improve morale and productivity and reduce workers' compensation costs. The success of these programmes relies on committed management, adequate risk assessment, hazard prevention and control and appropriate health and safety training.

Dr Roma Chilengi, Head of Clinical Trials at the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya gives an introduction to research ethics. This overview covers the historical origins and landmark events that have influenced current understanding of research ethics. Some of the major ethical codes and fundamental ethical principles are identified and their application in research is discussed. Finally, there is an overview of the role of ethics committees.

Dr Phaik Yeong Cheah, Head of Clinical Trials at the Mahidol-Oxford Research Unit in Bangkok, Thailand discusses clinical trial protocol development. This lecture is an introduction to the topic and gives an overview from initial concept through to GCP requirements, ethical considerations, study drugs and procedures and safety reporting.

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.