Clinical Trials

Clinical Trials: A Practical Guide ■❚❙❘Executive committeeThe executive committee is responsible and accountable for [9]:• proper design and conduct of a trial• ethical and professional standards of a trial• ensuring that the results of clinical trials and scientific endeavorsare arrived at in the most economical manner possible• considering and implementing any recommendations fromthe data and safety monitoring board (see below)Steering committeeThe steering committee is responsible for [9]:• guiding the overall conduct of the trial• ensuring that the trial protocol meets the highest scientific standards• protecting the rights and well-being of trial participantsIn some trials, only a steering committee is set up, taking the responsibilities ofboth the executive committee and the steering committee.Data and safety monitoring board or committeeThe independent data and safety monitoring board will regularly review interimdata from the trial and can recommend that the trial stop early for one of thefollowing reasons [10]:• The trial shows a large number of serious adverse events in oneof the treatment groups.• The trial shows a greater than expected benefit early into the trial.• It becomes clear that a statistically significant difference by the endof the trial is improbable (futility rule).• Logistical or data-quality problems are so severe that correctionis not feasible.Clinical event review committeeThe independent clinical event review committee, or endpoint committee, reviewsmajor clinical events (usually primary endpoints) that occur during the trial,and adjudicates or codes them into categories for later analyses.35