Methodological developments vs. regulatory requirements

DOI10.1002/BIMJ.200610244MaRDI QIDQ5122847zbMATH OpenOpenAlexWikidataFDO

Authors Peter Bauer

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.200610244

zbMATH Keywords

adaptive designsadaptive information designadaptive study designsbiostatisticsclinical trial simulationdropping a treatment armdrug safetyestimationexperimental designFDA critical pathguidance developmentmultiple endpointsnon-inferiority trialsphase III clinical trialsquantitative risk/safety assessmentregulatory biostatisticsregulatory evaluationsample size reassessmentstatistical efficiencystatistical informationsuperiority

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
• Opening the adaptive toolbox
• 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

(7)

• 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
• Opening the adaptive toolbox
• A consultant's perspective on the regulatory hurdles to adaptive trials
• Rejoinder

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