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

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 crit...

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Bibliografiske detaljer
Udgivet i:AMIA Annu Symp Proc
Main Authors: Li, Qian, Guo, Yi, He, Zhe, Zhang, Hansi, George, Thomas J, Bian, Jiang
Format: Artigo
Sprog:Inglês
Udgivet: American Medical Informatics Association 2021
Fag:
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC8075542/
https://ncbi.nlm.nih.gov/pubmed/33936446
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