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Chapter 14 - Practical Considerations for Adaptive Trial Designs and Master Protocols

from Part V - A Practical Guide to 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,
Edward J. Mills and
J. Kyle Wathen
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 chapter, we review practical considerations for adaptive trial designs and master protocols. Planning adaptive trial designs and master protocols require resources and time. It is best to plan ahead with key stakeholders with statistical, content, and operational expertise to make the trial possible. Customised education and training plans will likely be required for the vendors, investigators, and other personnel involved in the trial. Critical thinking is needed from the personnel involved to create flexible technology systems and procedures required to execute these clinical trials. During the conduct, it is important to document what happened, maintain a proper firewall, and manage external communications effectively. For long-term platform trials, study adjustments may be unavoidable, but it is important that these adjustments are made before the patients are enrolled into the new study arm.

Keywords

adaptive trial designsmaster protocolspractical considerations

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Chapter
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Introduction to Adaptive Trial Designs and Master Protocols , pp. 160 - 170
Publisher: Cambridge University Press
Print publication year: 2023

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