Interpreting Safety Analyses in Psoriasis Clinical Trials.

Abstract

Clinical trials are designed to evaluate the efficacy and safety of new drugs. However, greater focus is often placed on efficacy rather than safety. This review article discusses the fundamentals involved in evaluating the safety of a new drug. In addition, the principal challenges involved in the collection, analysis, reporting, and interpretation of safety data in clinical trials are described using relevant examples. These challenges include the fact that clinical trials are generally limited in size and duration, exclude high-risk populations, and have limited statistical power to detect rare but potentially serious adverse events (AEs) that might occur in real-world situations. Reporting of safety data across clinical trials is also inconsistent. A thorough understanding of the interpretation of safety data, especially the appropriate use of exposure-adjusted incidence rates (EAIRs) in relation to AEs, as well as the importance of comparing rates to those reported in the general population and in patients with psoriasis, is vital for making a well-informed assessment of the safety of a new drug. The information provided in this article could be useful to healthcare providers who must evaluate a large volume of safety data when providing evidence-based treatment suggestions and recommendations to their patients.