A Regulatory View on Adaptive/Flexible Clinical Trial Design

DOI10.1002/BIMJ.200610229MaRDI QIDQ5122841zbMATH OpenOpenAlexWikidataFDO

Authors

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.200610229

zbMATH Keywords

non-inferioritystatistical informationstatistical efficiencysuperiorityadaptive 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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Cited in

(7)

• Ethics, data-dependent designs, and the strategy of clinical trials: time to start learning-as-we-go?
• Challenges and regulatory experiences with non‐inferiority trial design without placebo arm
• Plan to be Flexible: A Commentary on Adaptive Designs
• Multicentre trials: a US regulatory perspective
• A consultant's perspective on the regulatory hurdles to adaptive trials
• Practical and statistical considerations in designing an early phase II osteoarthritis clinical trial: a case study
• Multicentre trials: a US regulatory perspective

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