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

DOI10.1002/BIMJ.201700307zbMATH Open1429.62492OpenAlexW2907979445WikidataQ90771528 ScholiaQ90771528MaRDI QIDQ5208201FDOQ5208201

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

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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)

Cited In (1)

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

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