Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research

Author:

Cruz Rivera Samantha123,Aiyegbusi Olalekan Lee124,Ives Jonathan5,Draper Heather6,Mercieca-Bebber Rebecca7,Ells Carolyn8,Hunn Amanda9,Scott Jane A.10,Fernandez Conrad V.11,Dickens Andrew P.112,Anderson Nicola1,Bhatnagar Vishal13,Bottomley Andrew14,Campbell Lisa15,Collett Clive16,Collis Philip117,Craig Kathrine18,Davies Hugh18,Golub Robert19,Gosden Lesley117,Gnanasakthy Ari20,Haf Davies Elin21,von Hildebrand Maria117,Lord Janet M.222324,Mahendraratnam Nirosha25,Miyaji Tempei26,Morel Thomas27,Monteiro Joao28,Zwisler Ann-Dorthe Olsen2930,Peipert John Devin31,Roydhouse Jessica3233,Stover Angela M.34,Wilson Roger13536,Yap Christina37,Calvert Melanie J.123423

Affiliation:

1. Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom

2. Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, United Kingdom

3. DEMAND Hub, University of Birmingham, Birmingham, United Kingdom

4. National Institute for Health and Care Research (NIHR) Applied Research Centre West Midlands, Birmingham, United Kingdom

5. Centre for Ethics in Medicine, Bristol Medical School, University of Bristol, Bristol, United Kingdom

6. Warwick Medical School, University of Warwick, Coventry, United Kingdom

7. NHMRC Clinical Trials Centre, Faculty of Medicine and Health, The University of Sydney, New South Wales, Australia

8. School of Population and Global Health, McGill University, Montreal, Quebec, Canada

9. A J Hunn Associates, London, United Kingdom

10. PRO Center of Excellence, Global Commercial Strategy Organization, Janssen Global Services, Warrington, United Kingdom

11. Division of Pediatric Haematology-Oncology, IWK Health Care Centre, Dalhousie University, Halifax, Nova Scotia, Canada

12. Observational and Pragmatic Research Institute, Midview City, Singapore

13. US Food and Drug Administration, Silver Spring, Maryland

14. European Organization for Research and Treatment of Cancer, Brussels, Belgium

15. Medicines and Healthcare Products Regulatory Agency, London, United Kingdom

16. Health Research Authority, London, United Kingdom

17. Patient partner, University of Birmingham, Birmingham, United Kingdom

18. Fast Track Research Ethics Committee, Health Research Authority, London, United Kingdom

19. JAMA Network, Chicago, Illinois

20. RTI Health Solutions, Research Triangle, North Carolina

21. Aparito Limited, Wrexham, Wales, United Kingdom

22. MRC-Versus Arthritis Centre for Musculoskeletal Ageing Research, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom

23. NIHR Birmingham Biomedical Research Centre, University Hospital Birmingham and University of Birmingham, Birmingham, United Kingdom

24. NIHR Surgical Reconstruction and Microbiology Research Centre, University Hospital Birmingham and University of Birmingham, Birmingham, United Kingdom

25. Aetion, Washington, DC

26. Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Bunkyo-ku, Tokyo, Japan

27. Global Patient-Centred Outcomes Research & Policy, UCB, Belgium, Brussels

28. Nature Medicine, New York, New York

29. Department of Cardiology, Odense University Hospital, Odense, Denmark

30. Clinical Institute, University of Southern Denmark, Odense, Denmark

31. Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois

32. Menzies Institute for Medical Research, University of Tasmania, Tasmania, Australia

33. Department of Health Services, Policy and Practice, Brown University School of Public Health, Providence, Rhode Island

34. University of North Carolina at Chapel Hill

35. Consumer Forum, National Cancer Research Institute, London, United Kingdom

36. Patient Involvement Network, Health Research Authority, London, United Kingdom

37. Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom

Publisher

American Medical Association (AMA)

Subject

General Medicine

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