[Methodological aspects of biostatistics and epidemiology in a clinical trial]

Various methodological issues in biostatistics and epidemiology which are relevant for the development of a clinical trial are discussed. A brief set of definitions regarding clinical trials and methods for the assignment of treatments is presented. In addition, methods to reduce the possibility of bias that may be introduced into a clinical trial are summarized. The different elements that must be included in the informed consent form are defined. General considerations for data analysis and for sample size required to obtain an adequate statistical power are illustrated. Finally, critical questions that can be used for the review of the literature on clinical trials are suggested.