Challenges in implementing adaptive designs: comments on the viewpoints expressed by regulatory statisticians

DOI10.1002/BIMJ.200610250MaRDI QIDQ5122844zbMATH OpenOpenAlexWikidataFDO

Authors 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 designsadaptive information designadaptive study designsbiostatisticsclinical trial simulationdropping a treatment armexperimental designFDA critical pathguidance developmentmissing datamultiple endpointsnon-inferioritynon-inferiority trialsphase III clinical trialsquantitative risk/safety assessmentregulatory evaluationsuperiority

Mathematics Subject Classification ID

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

Recommendations

• Adaptive designs from the viewpoint of an academic biostatistician
• Methodological developments vs. regulatory requirements
• Opening the adaptive toolbox
• A consultant's perspective on the regulatory hurdles to adaptive trials
• Rejoinder

Cited in

(8)

• FDA's critical path initiative: a perspective on contributions of biostatistics
• A Regulatory View on Adaptive/Flexible Clinical Trial Design
• Adaptive designs from the viewpoint of an academic biostatistician
• Opening the adaptive toolbox
• A consultant's perspective on the regulatory hurdles to adaptive trials
• Methodological developments vs. regulatory requirements
• Rejoinder
• Rejoinder to Discussions on “Approval policies for modifications to machine learning‐based software as a medical device: A study of bio‐creep”

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