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. 2020 Aug;17(4):377-382.
doi: 10.1177/1740774520905576. Epub 2020 Feb 17.

Regulatory-grade clinical trial design using real-world data

Mark S Levenson  1
Affiliations

Regulatory-grade clinical trial design using real-world data

Mark S Levenson. Clin Trials. 2020 Aug.

Abstract

Real-world data and evidence provide the potential to address the effectiveness and safety of drugs. The U.S. Food & Drug Administration has initiated a program to evaluate the potential use of real-world evidence for regulatory uses. Whether a study is designed for regulatory purposes or for other purposes, existing regulation and guidance provide a reference for high-quality studies. Clarifying the study objectives and the role of real-world data in the study are important considerations. Robustness and transparency of the analysis allow for greater understanding and acceptance of the study results.

Keywords: Evidence; bias; heterogeneity; real-world.

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References

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