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This public workshop provided a venue for stakeholders to highlight the pros and cons of design characteristics of large simple trials (LSTs), explore the utility of LSTs on the basis of case studies of past successes, and consider the challenges and opportunities for accelerating the use of LSTs in the context of a U.S. clinical trials enterprise that could benefit from increased implementation of simplified and streamlined clinical trial designs that produce generalizable results.
The workshop was convened by the Institute of Medicine's (IOM's) Roundtable on Value and Science-Driven Health Care and the Forum on Drug Discovery, Development, and Translation.
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