A consultant's perspective on the regulatory hurdles to adaptive trials

DOI10.1002/BIMJ.200610249MaRDI QIDQ5122846zbMATH OpenOpenAlexWikidataFDO

Authors Cyrus R. Mehta, Yannis Jemiai

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.200610249

zbMATH Keywords

adaptive designsadaptive information designbiostatisticsdropping a treatment armexperimental designflexible designnon-inferiorityphase III clinical trialsregulatory evaluationstatistical efficiencystatistical informationsuperiority

Mathematics Subject Classification ID

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

Recommendations

• Challenges in implementing adaptive designs: comments on the viewpoints expressed by regulatory statisticians
• Methodological developments vs. regulatory requirements
• Adaptive designs from the viewpoint of an academic biostatistician
• Opening the adaptive toolbox
• A Regulatory View on Adaptive/Flexible Clinical Trial Design

Cited in

(8)

• A Regulatory View on Adaptive/Flexible Clinical Trial Design
• 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
• Methodological developments vs. regulatory requirements
• Adaptive vs. group sequential self-designing trials
• Challenges and regulatory experiences with non‐inferiority trial design without placebo arm
• The changing landscape of data monitoring committees. Perspectives from regulators, members, and sponsors

This page was built for publication: A consultant's perspective on the regulatory hurdles to adaptive trials

Report a bug (only for logged in users!)Click here to report a bug for this page (MaRDI item Q5122846)