Key result
Independent DSMB monitoring should be required for early-phase trials to protect subject safety.
Randomized trial emphasizes the need for data safety monitoring in early and late-phase clinical trials, suggesting improvements for patient safety.
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.
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Gail A. Van Norman (2021) reported an editorial. Independent monitoring by a Drug Safety Monitoring Board (DSMB) should be required for many phase I and II clinical trials in addition to phase III studies to assure subject safety.
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