![Sample our Mathematics & Statistics journals, sign in here to start your FREE access for 14 days]({"type":"image" , "src" : "/sda/5943/TOC-Subject-Sample-2021-Mathematics-Statistics.jpg"})
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.
Disclosure statement
No potential conflict of interest was reported by the author.
Additional information
Notes on contributors
William G. Henderson
William G. Henderson, MPH, PhD, was the director of the Hines, IL, US Department of Veterans Affairs Cooperative Studies Program Coordinating Center for 24 years. In that time, he helped to plan, obtain approval and funding for, implement, conduct, analyse and publish over 40 cooperative studies in many different disease areas. He is currently a professor of biostatistics in the Adult and Child Consortium for Outcomes Research and Delivery Science (ACCORDS) at the University of Colorado Denver and professor in the Department of Biostatistics and Informatics in the School of Public Health, University of Colorado Denver.