FDA's critical path initiative: a perspective on contributions of biostatistics

DOI10.1002/BIMJ.200510237MaRDI QIDQ5122840zbMATH OpenOpenAlexWikidataFDO

Authors R. T. O'Neill

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.200510237

zbMATH Keywords

adaptive study designsclinical trial simulationFDA critical pathguidance developmentmissing datamultiple endpointsnon-inferiority trialsquantitative risk/safety assessmentregulatory biostatistics

Mathematics Subject Classification ID

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

Recommendations

• Rejoinder
• Methodological developments vs. regulatory requirements
• Opening the adaptive toolbox
• Adaptive designs from the viewpoint of an academic biostatistician
• Challenges in implementing adaptive designs: comments on the viewpoints expressed by regulatory statisticians

Cited in

(3)

• Sharing clinical trial data on patient level: opportunities and challenges
• Rejoinder
• Comments on: ``Twenty-five years of confirmatory adaptive designs: opportunities and pitfalls

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