Study Characteristics and Risk of Bias of Clinical Trials Supporting FDA Approval of Cardiovascular Drugs, 2006–2020

Abstract

Although randomized controlled trials are the standard for evaluating new drugs, problems in their design, conduct, analysis, and reporting can reduce the validity and reliability of their findings. In this study, we systematically summarized the study characteristics and performed risk of bias assessments of pivotal clinical trials supporting U.S. Food and Drug Administration (FDA) approval of cardiovascular drugs between 2006 and 2020.