Volume 30, Issue 3 - Medical decision making and health technology assessment
Master protocol studies: Embracing the “new normal”
Authors: Jonathan Mackinnon, Aitana Gisbert
Abstract
In a post-pandemic world, master protocol studies will be an integral part of the “new normal” for clinical research and play an important role in providing actionable data to support health policy and resource allocation. Medical writers and study teams alike will be expected to be fluent in the development of clear and coherent protocols to support these studies. Here we provide a brief orientation on master protocol study designs, protocol structures, and methods to support medical writers through the protocol development process.
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