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Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms
Published on: December 9, 2015
Overcoming the barriers to better evidence generation from clinical trials
Lindsay Kehoe1, Trevan Locke2, Mark McClellan2
1Clinical Trials Transformation Initiative, Duke University, Durham, NC, United States. Lindsay.kehoe@duke.edu.
Abstract:
Clinical evidence generation from and for representative populations can be improved through increased research access and ease of trial participation. To improve access and participation, a modern trial infrastructure is needed that broadens research into more routine practice. This commentary highlights current barriers, areas of advancement, and actions needed to enable continued transformation toward a modern trial infrastructure for an improved evidence generation system. The focus of this commentary is on the development of medical products (e.g., drugs, devices, biologics) and infrastructure issues within the United States, with the aim to have broader, multi-national applicability.
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