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Chapter 12 - Standards and Guidelines for Adaptive Trial Designs and Master Protocols

from Part IV - Case Studies of Adaptive Trial Designs and Master Protocols

Published online by Cambridge University Press:  20 March 2023

Jay J. H. Park ,
Edward J. Mills  and
J. Kyle Wathen
By
Jay J. H. Park ,
J. Kyle Wathen  and
Edward J. Mills
Jay J. H. Park
Affiliation:
McMaster University, Ontario
Edward J. Mills
Affiliation:
McMaster University, Ontario
J. Kyle Wathen
Affiliation:
Cytel, Cambridge, Massachusetts
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Summary

In this chpater, we review the standards and guidelines for adaptive trial designs and master protocols. Methodological rigour and transparent reporting are required in all clinical trials. Adaptive trial designs and master protocols are no exception. The standard reporting guidelines and risk-of-bias assessments for conventional trials can be applied to adaptive trial designs and master protocols. Adaptive trial designs have pre-planned adaptations and analysis plans that are specified in a formal way that outline how the data will be used to guide the design. Planning of adaptive clinical trials, basket trials, umbrella trials, and platform trials will require early engagement with the stakeholders and methodologists to think through potential hurdles and challenges of the statistical design and its implementation.

Keywords

adaptive trial designsmaster protocolsstandardsguidelines
Type
Chapter
Information
Introduction to Adaptive Trial Designs and Master Protocols , pp. 140 - 148
Publisher: Cambridge University Press
Print publication year: 2023

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