Overview of Clinical Trials

Abstract

Data emanating from randomised controlled clinical trials are regarded as the highest level of evidence when evaluating new drugs, vaccines or health interventions and hence in undertaking these types of studies at CAPRISA this study design has been used extensively. This chapter describes key elements of clinical trials, such as blinding and randomisation, and how CAPRISA has implemented these elements. The limitations of clinical trials and when other designs would be more applicable to the research question being asked are also described. The implementation of less traditional designs, such as cluster randomised trials and factorial designs is also described.