Opening the adaptive toolbox

DOI10.1002/BIMJ.200610240MaRDI QIDQ5122845zbMATH OpenOpenAlexWikidataFDO

Authors Peter A. Lachenbruch, Janet Wittes

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.200610240

zbMATH Keywords

experimental designmissing datanon-inferiorityadaptive designsbiostatisticsstatistical informationnon-inferiority trialsmultiple endpointsstatistical efficiencysuperiorityphase III clinical trialsclinical trial simulationadaptive information designadaptive study designsdropping a treatment armFDA critical pathguidance developmentquantitative risk/safety assessmentregulatory biostatisticsregulatory evaluation

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
• Challenges in implementing adaptive designs: comments on the viewpoints expressed by regulatory statisticians
• A consultant's perspective on the regulatory hurdles to adaptive trials
• Rejoinder

Cited in

(8)

• Rejoinder
• Editorial -- Adaptive designs: expectations are high
• FDA's critical path initiative: a perspective on contributions of biostatistics
• Adaptive designs from the viewpoint of an academic biostatistician
• Challenges in implementing adaptive designs: comments on the viewpoints expressed by regulatory statisticians
• A consultant's perspective on the regulatory hurdles to adaptive trials
• Methodological developments vs. regulatory requirements
• How practical are adaptive designs likely to be for confirmatory trials?

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