Article

Using Real-World Data to Rationalize Clinical Trials Eligibility Criteria Design: A Case Study of Alzheimer’s Disease Trials

2020-08-04

Abstract excerpt

Low trial generalizability is a concern. The Food and Drug Administration had guidance on broadening trial eligibility criteria to enroll underrepresented populations. However, investigators are hesitant to do so because of concerns over patient safety. There is a lack of methods to rationalize criteria design. In this study, we used data from a large research network to assess how adjustments of eligibility crite...

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Literature Corpus work: 05350196-470f-582f-9044-5e6cdf1c35b3
DOI: 10.1101/2020.08.02.20166629

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