When Can Nonrandomized Studies Support Valid Inference Regarding Effectiveness or Safety of New Medical Treatments?-Reference-Cited by-同舟云学术

When Can Nonrandomized Studies Support Valid Inference Regarding Effectiveness or Safety of New Medical Treatments?

Published:2021-05-09 Issue:1 Volume:111 Page:108-115
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Franklin Jessica M.¹²,Platt Richard³,Dreyer Nancy A.⁴,London Alex John⁵,Simon Gregory E.⁶,Watanabe Jonathan H.⁷,Horberg Michael⁸,Hernandez Adrian⁹,Califf Robert M.¹⁰

Affiliation:

1. Optum Epidemiology Boston Massachusetts USA

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

3. Harvard Pilgrim Health Care Institute Harvard Medical School Boston Massachusetts USA

4. IQVIA Real World Solutions Cambridge Massachusetts USA

5. Philosophy Department & Center for Ethics and Policy Carnegie Mellon University Pittsburgh Pennsylvania USA

6. Kaiser Permanente Washington Health Research Institute Seattle Washington USA

7. School of Pharmacy and Pharmaceutical Sciences University of California Irvine Irvine California USA

8. Kaiser Permanente Mid‐Atlantic Permanente Research Institute and Mid‐Atlantic Permanente Medical Group Bethesda Maryland USA

9. Duke Clinical Research Institute Durham North Carolina USA

10. Verily Life Sciences and Google Health Cambridge Massachusetts USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.2255

Reference74 articles.

1. Randomized, Controlled Trials, Observational Studies, and the Hierarchy of Research Designs

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

3. When and How Can Real World Data Analyses Substitute for Randomized Controlled Trials?

4. 21st Century Cures Act HR 34 114th Congress (2015–2016). (2016). Accessed June 15 2017.

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

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