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Dissecting Adaptive Design
- Article from:
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Applied Clinical Trials
- Article date:
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May 1, 2008
- Author:
- Miller, Eva R; Ehinger, Marisa; Shea, Ellen; Higgins, Valarie
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Copyright informationCopyright Advanstar Communications, Inc. May 2008. Provided by ProQuest LLC. (Hide copyright information)
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Team and technology benefits are realized at the front-end of the adaptive trial design process.
Adaptive or flexible trial design refers to a conceptual clinical trial methodology that allows for modifications to take place after the trial has started without compromising the scientific method. For all forms of adaptive design, the important distinction that is critical to maintaining the research perspective is that the decisionmaking rules governing the adaptation must be clearly stated (described and justified) in the study protocol.
In an adaptive design setting, sponsors are empowered to make modifications in response to data collected during the trial as long as the response action ...