Titlebook: Data Monitoring Committees (DMCs); Past, Present, and F Nand Kishore Rawat,David Kerr Book 2023 The Editor(s) (if applicable) and The Autho

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https://doi.org/10.1007/978-3-031-79986-0 used must ensure integrity of study results. Numerous examples are provided to illustrate key concepts such as the O’Brien Fleming error spending function for generating early stopping boundaries, and use of conditional power, for futility stopping or to identify the promising zone for sample size re-assessment.

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Is a DMC Required? What Other Groups Are Involved?,es. Differences in DMC process for open-label and single-arm studies (typically Phase 1 and Phase 2 studies) are highlighted, contrasting from randomized blinded controlled studies (typically Phase 3 studies).

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Book 2023tsfor the future. Previous works focused primarily on largecardiovascular studies (where DMCs originated more than 30 years ago)but updated references are needed that discuss smaller, more flexiblestudies in areas such as oncology. The authors have attended ~800 DMCmeetings from ~200 distinct studie

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