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

Author:

Franklin Jessica M.1,Schneeweiss Sebastian1

Affiliation:

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

Funder

Brigham and Women's Hospital

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference79 articles.

1. Bonamici S H.R.34 - 114th Congress (2015-2016): 21st Century Cures Act https://www.congress.gov/bill/114th-congress/house-bill/34 2016

2. U.S. Food and Drug Administration Prescription Drug User Fee Act (PDUFA) - PDUFA VI: Fiscal Years 2018-2022 https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm446608.htm 2017

3. A review of uses of health care utilization databases for epidemiologic research on therapeutics;Schneeweiss;J. Clin. Epidemiol.,2005

4. Assessing the comparative effectiveness of newly marketed medications: methodological challenges and implications for drug development;Schneeweiss;Clin. Pharmacol. Ther.,2011

5. Improving therapeutic effectiveness and safety through big healthcare data;Schneeweiss;Clin. Pharmacol. Ther.,2016

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