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Stopping Trials Early for Benefit: Overestimating Effects and Putting Patients at Risk

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February 28, 2023

Stopping Trials Early for Benefit: Overestimating Effects and Putting Patients at Risk

Vol: 6| Issue: 2| Number:1| ISSN#: 2563-559X

Authored By: Steve Phillips, Sushmitha Pallapothu, Selina Bains, Ellen Scholl and Mohit Bhandari on Behalf of OrthoEvidence

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Conducting a randomized controlled trial (RCT) can be a substantial undertaking, taking considerable time and money. The evolution of RCTs has allowed different mechanisms for stopping trials early, the main three of which are stopping trials early for harm, stopping trials early for futility, and stopping trials early for benefit. ​​​​​​​Stopping a trial early is usually done at a pre-planned interim analysis, where efficacy and safety are evaluated by a Data Safety Monitoring Committee (DSMC) and predetermined stopping criteria are used in order to determine whether the trial should be halted, either for harm, futility, or benefit. Criteria for stopping a trial for harm are common in drug trials and are considered necessary  for patient safety. At an interim analysis, the number of adverse events......
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