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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
Authors:Shirley V. Wang  Anton Pottegård  William Crown  Peter Arlett  Darren M. Ashcroft  Eric I. Benchimol  Marc L. Berger  Gracy Crane  Wim Goettsch  Wei Hua  Shaum Kabadi  David M. Kern  Xavier Kurz  Sinead Langan  Takahiro Nonaka  Lucinda Orsini  Susana Perez-Gutthann  Simone Pinheiro  Nicole Pratt  Sebastian Schneeweiss  Massoud Toussi  Rebecca J. Williams
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. Independent Consultant, New York, USA;8. Roche Pharmaceuticals, Camberley, UK;9. The National Health Care Institute, Diemen, The Netherlands

Utrecht University, Utrecht, The Netherlands;10. US Food and Drug Administration, Silver Springs, Maryland, USA;11. Sanofi-Aventis US LLC, North Potomac, Maryland, USA;12. Janssen Research & Development, LLC, Philadelphia, Pennsylvania, USA;13. London School of Tropical Hygiene, London, UK;14. Pharmaceutical and Medical Devices Agency, Japan;15. COMPASS Pathways Ltd, Skillman, UK;16. RTI Health Solutions, Barcelona, Spain;17. Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences, University of South Australia, South Australia, Australia;18. IQVIA, France;19. Bethesda, Maryland, USA

Abstract:
Keywords:protocol  real world evidence  reproducibility  transparency
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