Challenges in Implementing Adaptive Designs: Comments on the Viewpoints Expressed by Regulatory Statisticians

DOI10.1002/bimj.200610250zbMath1442.62371OpenAlexW2036748314WikidataQ80261875 ScholiaQ80261875MaRDI QIDQ5122844

Paul P. Gallo, Willi Maurer

Publication date: 24 September 2020

Published in: Biometrical Journal (Search for Journal in Brave)

Full work available at URL: https://doi.org/10.1002/bimj.200610250

zbMATH Keywords

adaptive designsmissing dataexperimental designnon-inferioritybiostatisticsnon-inferiority trialsmultiple endpointssuperiorityphase III clinical trialsclinical trial simulationadaptive study designsFDA critical pathguidance developmentquantitative risk/safety assessmentadaptive information designdropping a treatment armregulatory evaluation

Mathematics Subject Classification ID

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

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