Clinical Trial Protocol Development

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.

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.

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 Roma Chilengi, Head of Clinical Trials at the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya gives an introduction to ICH-GCP. This overview covers the historical background, context and evolution to ICH-GCP, summarises its key principles and describes the role of regulatory authorities. The talk highlights some of the accomplishments of ICH-GCP but also critiques some aspects of GCP application in non-pharmaceutical 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.