Clinical trials design and conduct

ABSTRACT This article attempts to outline the most important aspects to consider when planning a randomized controlled clinical trial (RCT) and writing a proposal for the RCT. RCTs are generally formulated by a planning committee that should be comprised of members with expertise in the different important features of the trial. Important considerations include background, objectives/hypotheses, experimental design, patient population and recruitment/retention plan, stratification/randomization, experimental treatment, control or comparison treatment, blinding, primary and secondary outcomes, patient follow-up, data to be collected, capture of data and confidentiality, handling of adverse events, sample size/statistical power and feasibility, statistical analysis, ethical issues, and governance of the trial. Real world examples, mostly drawn from the US Department of Veterans Affairs Cooperative Studies Program, are used to illustrate the various important considerations.