Data Safety and Monitoring Boards Should Be Required for Both Early- and Late-Phase Clinical Trials

Phase I and II clinical trials increasingly combine therapeutic and toxicity endpoints. Recently, therapeutic agents have even achieved U.S. Food and Drug Agency approval based on early phase trials alone. These developments point to new challenges in assuring the safety of human research subjects and patients. Given their size and use of real-world patients, phase III studies warrant independent monitoring by a Drug Safety Monitoring Board (DSMB). Requirements should also be extended to include many phase I and II clinical trials. Measures should be taken to establish and standardize minimum qualifications for service on a DSMB. (C) 2021 The Author. Published by Elsevier on behalf of the American College of Cardiology Foundation.

Automated summary

Phase I and II clinical trials are integrating therapeutic and toxicity endpoints more, with some therapeutic agents gaining FDA approval based on early phase trials alone. It is suggested that independent monitoring by DSMB is necessary for phase III studies and possibly extended to many phase I and II clinical trials. Minimum qualifications for DSMB service should be established and standardized.