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Title: Picking outcomes for outpatient platform trials in a pandemic Authors:  Christopher Lindsell - Vanderbilt University Medical Center (United States) [presenting]
Abstract: One of the most important decisions in a clinical trial is which outcome to use. The preferred outcome for the same trial may depend on the viewpoint of the stakeholder consuming the results, and the intended policy or regulatory impacts. During the Covid-19 pandemic, we were asked to design a platform trial to test whether existing therapies with a known safety profile could be repurposed to help mild to moderately ill outpatients with Covid-19 get better faster, and stay out of the hospital. In this context, there are many different viewpoints as to the most important question, and the relevant question might change over time. The balance between generating evidence is reviewerd quickly using sensitive outcomes and generating sufficient evidence to support regulatory claims, and between a decentralized pragmatic trial deployed nationwide and a controlled clinical trial intended for supporting registrational claims.