The changing landscape of data monitoring committees. Perspectives from regulators, members, and sponsors

DOI10.1002/BIMJ.201700307MaRDI QIDQ5208201zbMATH OpenOpenAlexWikidataFDO

Authors Amit Bhattacharyya, Paul P. Gallo, Adam Crisp, Lisa M. Lavange, Geert Molenberghs, Frank Pétavy, Jonathan Seltzer

Publication date 15 January 2020

Published in Biometrical Journal (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1002/bimj.201700307

zbMATH Keywords

clinical trialfutilityadaptive designdata monitoring committee (DMC)EMAregulatory guidelineUS FDA

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10)

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• Sharing clinical trial data on patient level: opportunities and challenges

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