Methods for external control groups for single arm trials or long‐term uncontrolled extensions to randomized clinical trials-Reference-Cited by-同舟云学术

Methods for external control groups for single arm trials or long‐term uncontrolled extensions to randomized clinical trials

Published:2020-10-04 Issue:11 Volume:29 Page:1382-1392
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Seeger John D.¹^ORCID,Davis Kourtney J.²,Iannacone Michelle R.³,Zhou Wei⁴,Dreyer Nancy⁵,Winterstein Almut G.⁶,Santanello Nancy⁷,Gertz Barry⁸,Berlin Jesse A.²

Affiliation:

1. Life Sciences Epidemiology, Optum Boston Massachusetts USA

2. Global Epidemiology, Johnson & Johnson Titusville New Jersey USA

3. Center for Biologics Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USA

4. Pharmacoepidemiology, Merck & Co., Inc. Kenilworth New Jersey USA

5. Real‐World Solutions, IQVIA Cambridge Massachusetts USA

6. University of Florida Gainesville Florida USA

7. Nancy Santanello Research Consultant Philadelphia Pennsylvania USA

8. Blackstone Cambridge Massachusetts USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.5141

Reference36 articles.

1. Why Did the Randomized Clinical Trial Become the Primary Focus of My Career?

2. The importance of randomized clinical trials and evidence-based medicine: A clinician's perspective

3. The evolution of the randomized controlled trial and its role in evidence-based decision making

4. The Emergence of the Randomized, Controlled Trial

5. The role of nonrandomized trials in the evaluation of oncology drugs

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