How to choose a time zero for patients in external control arms
Author:
Affiliation:
1. Quantitative Sciences Janssen Research and Development LLC Raritan New Jersey USA
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology,Statistics and Probability
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2107
Reference14 articles.
1. Accelerating anticancer drug development — opportunities and trade-offs
2. Accelerated Approval of Oncology Products: The Food and Drug Administration Experience
3. Trial designs using real‐world data: The changing landscape of the regulatory approval process
4. Role of real-world evidence for oncology product registration in the United States: A review of approvals by the U.S. Food and Drug Administration from 2015 to 2019.
5. Real‐world evidence to support regulatory decision‐making for medicines: Considerations for external control arms
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