Adequate use of biostatistics in biopharmacy and clinical studies: Critical elements and types of products studied

Abstract

Background: Biostatistics are often used incorrectly in clinical studies of different types of products such as drugs, medical devices or dietary supplements. The safety and efficacy of the studied products is affected by such inappropriate use of biostatistics. Methods: This analysis is a review of several studies, showing the risks of using biostatistics incorrectly, as well as the misinterpretation of the data that may occur. The proper proceedings in the pre-study phase and post-study analytical phase are presented. Conclusions: These elements have major impacts on the development of clinical trials, regardless of the type of product investigated.