An Introduction to 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 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.

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 requirements for setting up a laboratory in resource-poor settings. From logistics planning to infrastructure development to setting up quality systems, this lecture gives a concise overview of the challenges facing laboratories based in resource-poor settings and provides some constructive advice.

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.

Dr Roma Chilengi, Head of Clinical Trials at the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya discusses clinical trial data safety monitoring boards (DSMBs). This introduction starts with a definition of a DSMB and discusses their roles and when they are required. DSMS constitutions, charters and considerations for under developed settings are also discussed.