Pitfalls in the Design and Evaluation of Clinical Trials of Intravenously Administered Cardiovascular Drugs

Abstract

Studies that evaluate the efficacy of cardiovascular drugs vary greatly in their protocol design and choice of therapeutic endpoints. Yet, not all protocol designs can provide compelling evidence for the utility of a new drug; some designs are sufficiently flawed to make an interpretable outcome unlikely. Similarly, not all endpoints provide similarly strong evidence of efficacy. A clear distinction should always be made between endpoints that establish the activity and those than establish the efficacy of a new drug, particularly when a surrogate endpoint is used as the primary measure of the utility of an experimental agent.