Randomized, observational, interventional, and real‐world—What's in a name?-Reference-Cited by-同舟云学术

Randomized, observational, interventional, and real‐world—What's in a name?

Published:2020-09-17 Issue:11 Volume:29 Page:1514-1517
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Concato John¹^ORCID,Stein Peter²,Dal Pan Gerald J.³,Ball Robert³^ORCID,Corrigan‐Curay Jacqueline¹

Affiliation:

1. Office of Medical Policy Center for Drug Evaluation and Research, Food and Drug Administration Silver Spring Maryland USA

2. Office of New Drugs Center for Drug Evaluation and Research, Food and Drug Administration Silver Spring Maryland USA

3. Office of Surveillance and Epidemiology Center for Drug Evaluation and Research, Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.5123

Reference10 articles.

1. Real-World Evidence — What Is It and What Can It Tell Us?

2. Adequate and well‐controlled studies. 21 C.F.R. § 314.126 (2002).

3. H.R. 34—114th Congress: 21st Century Cures Act. 2016. Available fromhttps://www.govtrack.us/congress/bills/114/hr34. Accessed January 5 2020.

4. US Food and Drug Administration(FDA). Framework for FDA's Real‐World Evidence Program. 2018. Available fromhttps://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RealWorldEvidence/UCM627769.pdf. Accessed January 5 2020.

5. Pragmatic Trials

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