Planning a Randomized Clinical Trial

Summary: A high-quality clinical study often requires as much time in planning and preparation as it does in its execution. Although there are hundreds of steps required in the development of a study plan, this article focuses on important considerations that should be addressed in all study plans. These include: 1) asking clinically important questions, 2) conducting comprehensive literature searches, 2) refining the study question after the literature search, 3) choosing the appropriate study methodology (eligibility and outcomes), 4) determining study sample size, 5) identifying research team members, 6) writing the complete study proposal, 7) obtaining ethics approval, and 8) applying for funding.