A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real‐World Evidence for Regulatory Decisions-Reference-Cited by-同舟云学术

A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real‐World Evidence for Regulatory Decisions

Published:2019-06-12 Issue:1 Volume:106 Page:103-115
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Gatto Nicolle M.¹²³,Reynolds Robert F.¹²,Campbell Ulka B.¹³

Affiliation:

1. EpidemiologyPfizer Inc. New York New York USA

2. Department of EpidemiologyTulane School of Public Health and Tropical Medicine New Orleans Louisiana USA

3. Department of EpidemiologyMailman School of Public HealthColumbia University New York New York USA

Funder

Pfizer

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1480

Reference37 articles.

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2. US Food and Drug Administration (FDA).Framework for FDA's Real‐World Evidence Program. 1−37 (2018). Accessed April 15 2019

3. Evaluating the Use of Nonrandomized Real‐World Data Analyses for Regulatory Decision Making

4. Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making

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