Key result
Data safety monitoring boards evaluate early randomized trial termination based on efficacy, futility, and harm.
Why the study?
This review article aims to explain the important issues that data safety monitoring boards face when considering early termination of a randomized clinical trial for clinical and research cardiologists.
This review provides clinical and research cardiologists with an overview of the principles and regulatory aspects guiding DSMB decisions to terminate clinical trials early.
Guides DSMB oversight in cardiology trials; leaves open standardization of stopping rules for future studies.
This review article aims to explain the important issues that data safety monitoring boards (DSMB) face when considering early termination of a trial and is specifically addressed to the needs of clinical and research cardiologists. We give an insight into the overall background and then focus on the three principal reasons for stopping trials, i.e. efficacy, futility, and harm. The statistical essentials are also addressed to familiarize clinicians with the key principles. The topic is further highlighted by numerous examples from lipid trials and antithrombotic trials. This is followed by an overview of regulatory aspects, including an insight into industry-investigator interactions. To conclude, we summarize the key elements that are the basis for a decision to stop a randomized clinical trial (RCT).
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Drexel et al. (2020) conducted a review in Cardiovascular pharmacotherapy trials. Data safety monitoring boards evaluate early termination of randomized clinical trials based on three principal reasons: efficacy, futility, and harm.
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