Nonrandomized Real‐World Evidence to Support Regulatory Decision Making: Process for a Randomized Trial Replication Project-Reference-Cited by-同舟云学术

Nonrandomized Real‐World Evidence to Support Regulatory Decision Making: Process for a Randomized Trial Replication Project

Published:2019-10-25 Issue:4 Volume:107 Page:817-826
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Franklin Jessica M.¹^ORCID,Pawar Ajinkya¹^ORCID,Martin David²,Glynn Robert J.¹,Levenson Mark³,Temple Robert⁴,Schneeweiss Sebastian¹^ORCID

Affiliation:

1. Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women's Hospital Harvard Medical School Boston Massachusetts USA

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

3. Division of Biometrics VII Office of Biostatistics Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

4. Office of Drug Evaluation I Office of New Drugs Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1633

Reference45 articles.

1. Bonamici S.H.R.34 ‐ 114th Congress (2015–2016): 21st Century Cures Act (Published December 13 2016). Accessed June 15 2017.

2. US Food and Drug Administration.Prescription Drug User Fee Act (PDUFA) – PDUFA VI: Fiscal Years 2018–2022. Accessed June 15 2017.

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

4. Multidimensional Evidence Generation and FDA Regulatory Decision Making

5. Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials;Anglemyer A.;Cochrane Database Syst Rev.,2014

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