Designing and Deciphering Clinical Trials

Abstract This chapter distills the essential components required for designing clinical trials of high methodological quality and reproducibility into a user-friendly instruction manual complete with checklists, charts, and algorithms. Because these are the same components and procedures required for evaluating the strength of published research, the practice of critical appraisal also is considered. To accomplish these parallel goals, the authors focus on a “baker’s dozen” design features: asking the right question, randomization, allocation concealment, masked assessment, baseline patient characteristics, inclusion and exclusion criteria, accounting for clinical trial participants, intention-to-treat, primary and secondary outcomes, sample size calculation, evaluating benefits and harms, interpreting results, and managing conflict of interest. The chapter concludes with a hope and a prayer.