HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real‐world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force-Reference-Cited by-同舟云学术

HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real‐world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force

Published:2022-10-10 Issue:1 Volume:32 Page:44-55
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiology and Drug

Author:

Wang Shirley V.¹^ORCID,Pottegård Anton²^ORCID,Crown William³,Arlett Peter⁴,Ashcroft Darren M.⁵,Benchimol Eric I.⁶⁷⁸^ORCID,Berger Marc L.⁹,Crane Gracy¹⁰,Goettsch Wim¹¹¹²,Hua Wei¹³,Kabadi Shaum¹⁴,Kern David M.¹⁵,Kurz Xavier⁴^ORCID,Langan Sinead¹⁶,Nonaka Takahiro¹⁷,Orsini Lucinda¹⁸,Perez‐Gutthann Susana¹⁹^ORCID,Pinheiro Simone¹³,Pratt Nicole²⁰^ORCID,Schneeweiss Sebastian¹^ORCID,Toussi Massoud²¹,Williams Rebecca J.²²

Affiliation:

1. Brigham and Women's Hospital Harvard Medical School Boston Massachusetts USA

2. University of Southern Denmark Odense Denmark

3. Brandeis University Waltham Massachusetts USA

4. European Medicines Agency London UK

5. School of Health Sciences University of Manchester Manchester UK

6. Child Health Evaluative Sciences SickKids Research Institute Toronto Ontario Canada

7. ICES Toronto Ontario Canada

8. Department of Paediatrics and Institute of Health Policy, Management and Evaluation, The Hospital for Sick Children University of Toronto Toronto Ontario Canada

9. Independent Consultant New York USA

10. Roche Pharmaceuticals Camberley UK

11. The National Health Care Institute Diemen The Netherlands

12. Utrecht University Utrecht The Netherlands

13. US Food and Drug Administration Silver Springs Maryland USA

14. Sanofi‐Aventis US LLC North Potomac Maryland USA

15. Janssen Research & Development, LLC Philadelphia Pennsylvania USA

16. London School of Tropical Hygiene London UK

17. Pharmaceutical and Medical Devices Agency Japan

18. COMPASS Pathways Ltd Skillman UK

19. RTI Health Solutions Barcelona Spain

20. Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences University of South Australia South Australia Australia

21. IQVIA France

22. Bethesda Maryland USA

Funder

National Health and Medical Research Council

National Institute on Aging

National Heart, Lung, and Blood Institute

National Institutes of Health

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.5507

Reference63 articles.

1. US Food and Drug Administration.Framework for FDA's Real World Evidence Program 20182018. Accessed January 31 2019.https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RealWorldEvidence/UCM627769.pdf

2. Real world evidence: experience and lessons from China

3. Elements of real world data/evidence quality throughout the prescription drug product life cycle. Government of Canada2019. Accessed May 5 2020 https://www.canada.ca/en/services/health/publications/drugs‐health‐products/real‐world‐data‐evidence‐drug‐lifecycle‐report.html.

4. The FDA's sentinel initiative-A comprehensive approach to medical product surveillance

5. Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)

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