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Chapter 7 - Platform Trials

from Part III - Basic Ingredients for 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 chapter, we review the concept of platform trials in close detail. Platform trials refer to clinical trials that allow new interventions to be added to the platform over time even, if they are not pre-specified in the design stage. Platform trials can be applied to all phases of clinical trial research. While they are most often conducted as randomised clinical trials with adaptive trial designs (adaptive platform randomised trials), they can be conducted with non-randomised or fixed sample trial designs as well. As a general goal, platform trials aim to establish a shared trial infrastructure where multiple interventions can be evaluated. Independent clinical trial evaluation would result in multiple separate teams creating shorter term infrastructure and trials that would otherwise compete against each other. Platform trials represent an exciting turning point for clinical research. The key design considerations of platform trials are outlined in this chapter.

Keywords

platform trialsMAMSadaptive platform trialsmulti-arm, multi-stage design
Type
Chapter
Information
Introduction to Adaptive Trial Designs and Master Protocols , pp. 73 - 86
Publisher: Cambridge University Press
Print publication year: 2023

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