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Using Real-World Data to Rationalize Clinical Trials Eligibility Criteria Design: A Case Study of Alzheimer's Disease Trials
2020-08-04
health informatics
Title + abstract only
View on medRxiv
Show abstract
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 criteria can jointly affect generalizability and patient safety (i.e the number of serio...
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