Harnessing the Power of Real-World Evidence (RWE): A Checklist to Ensure Regulatory-Grade Data Quality-Reference-Cited by-同舟云学术

Harnessing the Power of Real-World Evidence (RWE): A Checklist to Ensure Regulatory-Grade Data Quality

Published:2017-12-06 Issue:2 Volume:103 Page:202-205
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Miksad Rebecca A.¹,Abernethy Amy P.¹

Affiliation:

1. Flatiron Health, Inc.; New York New York USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference5 articles.

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3. FDA guidance: Use of real-world evidence to support regulatory decision-making for medical devices Silver Spring, MD US Food and Drug Administration

4. Real-world data for clinical evidence generation in oncology;Khozin;J. Natl. Cancer Inst.,2017

5. Regulatory watch: from big data to smart data: FDA's INFORMED initiative;Khozin;Nat. Rev. Drug Discov.,2017

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