External Control Arms: We're Not on Cruise Control Yet
Author:
Affiliation:
1. Division of Cardiometabolic and Endocrine Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland USA
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2963
Reference10 articles.
1. The combination of randomized and historical controls in clinical trials
2. The “Coming of Age” of Real‐World Evidence in Drug Development and Regulation
3. Development of an External Control Arm Using Electronic Health Record‐Based Real‐World Data to Evaluate the Efficacy of COVID‐19 Treatment
4. FDA guidance for industry: considerations for the design and conduct of externally controlled trials for drug and biological products. . (February2023).
5. FDA guidance for industry: demonstrating substantial evidence of effectiveness for human drug and biological products. . (December2019).
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