Clinical Trials

Clinical trials prospectively compare different interventions in two or more groups. Such trials objectively measure health interventions’ safety, efficacy, and effectiveness. Drug therapy, surgery, or behavioral interventions can all be assessed with clinical trials. Clinical trials can assess the efficacy of interventions when tested on individual patients in health facilities or in larger groups in the community. Randomized controlled trials (RCTs) are the gold standard of clinical trials and provide the strongest evidence base for deciding on the effectiveness and safety of health interventions. Rigorous standards have been adopted for designing, conducting, analyzing, and reporting clinical trials. Adhering to such standards allows the comparison of results between studies and minimizes the risk of the researcher conducting the study, or other factors, from biasing the results. Ethical considerations are an especially important consideration in the conduct of clinical trials. Before initiation of the trial, the researcher proposing the trial should ensure that the question being addressed has not yet been answered and that there is true uncertainty (“equipoise”) about the efficacy or safety of the interventions being compared. Equally importantly, participants in the trial should fully understand the nature of the study they are asked to participate in and any risks that participation in the study entails.