Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making

Author:

Schneeweiss S1,Eichler H-G2,Garcia-Altes A3,Chinn C4,Eggimann A-V5,Garner S6,Goettsch W7,Lim R8,Löbker W9,Martin D10,Müller T9,Park BJ11,Platt R12,Priddy S13,Ruhl M14,Spooner A15,Vannieuwenhuyse B16,Willke RJ17

Affiliation:

1. Division of Pharmacoepidemiology (DoPE), Department of Medicine; Brigham & Women's Hospital; Boston Massachusetts USA

2. European Medicines Agency (EMA); London United Kingdom

3. Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS); Barcelona Spain

4. Sanofi; Paris France

5. Bluebird Bio, Inc.; Cambridge Massachusetts USA

6. National Institute for Health and Care Excellence (NICE); London United Kingdom

7. National Health Care Institute, Diemen and Division of Pharmacoepidemiology and Clinical Pharmacology; Utrecht Institute for Pharmaceutical Sciences; Utrecht The Netherlands

8. Health Products and Food Branch; Health Canada; Ottawa Ontario Canada

9. Gemeinsamer Bundesausschuss (GBA); Abteilung Arzneimittel; Berlin Germany

10. Center for Drug Evaluation and Research; U.S. Food and Drug Administration; Silver Spring Maryland USA

11. Seoul National University, College of Medicine, Department of Preventive Medicine; Seoul South Korea

12. Department of Population Medicine; Harvard Medical School and Harvard Pilgrim Healthcare Institute; Boston Massachusetts USA

13. Comprehensive Health Insights (CHI), Humana; Louisville Kentucky USA

14. Aetion Inc.; New York NY USA

15. Health Products Regulatory Authority (HPRA); Dublin Ireland

16. Innovative Medicine Initiative - European Medical Information Framework, Janssen Pharmaceutica Research and Development; Beerse Belgium

17. International Society for Pharmacoeconomics and Outcomes Research; Lawrenceville New Jersey USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference70 articles.

1. FDA designations for therapeutics and their impact on drug development and regulatory review outcomes;Kesselheim;Clin. Pharmacol. Ther.,2015

2. Adaptive licensing: taking the next step in the evolution of drug approval;Eichler;Clin. Pharmacol. Ther.,2012

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

4. Guidelines for good pharmacoepidemiology practices (GPP);The International Society of Pharmacoepidemiology;Pharmacoepidemiol. Drug Saf.,2008

5. Federal Register Guidance for industry and Food and Drug Administration staff on best practices for conducting and reporting pharmacoepidemiologic safety studies using electronic healthcare data; availability https://www.federalregister.gov/documents/2013/05/14/2013-11361/guidance-for-industry-and-food-and-drug-administration-staff-on-best-practices-for-conducting-and

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