Setting-up a clinical trial: Some methodological recommendations

Well-designed clinical trials are the gold standard for evidence-based research and for the assessment of the effectiveness of a clinical intervention. Methodological guidelines are available from various sources, such as textbook, funding applications and institutional guidelines. Nevertheless, a high number of published trials still lack methodological rigor, decreasing their utility, quality and scientific validity. In this article, we aim at providing some methodological recommendations for the development and report of a clinical trial, including the definition and recruitment of the sample, the basic study designs, randomization, blindness, data analysis and data report. Finally, we will discuss some of the most important ethical issues.