Journal
JACC-BASIC TO TRANSLATIONAL SCIENCE
Volume 6, Issue 11, Pages 887-896Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacbts.2021.09.005
Keywords
clinical trials; Data Safety and Monitoring Board (DSMB); drug and device approval; Institutional Review Board (IRB); monitoring; safety
Categories
Funding
- American College of Cardiology
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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.
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.
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