Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols

Author:

Calvert Melanie1,Kyte Derek1,Mercieca-Bebber Rebecca2,Slade Anita1,Chan An-Wen3,King Madeleine T.2,Hunn Amanda4,Bottomley Andrew5,Regnault Antoine6,Chan An-Wen7,Ells Carolyn8,O’Connor Daniel9,Revicki Dennis10,Patrick Donald11,Altman Doug12,Basch Ethan13,Velikova Galina14,Price Gary15,Draper Heather16,Blazeby Jane17,Scott Jane18,Coast Joanna17,Norquist Josephine19,Brown Julia14,Haywood Kirstie16,Johnson Laura Lee20,Campbell Lisa9,Frank Lori21,von Hildebrand Maria15,Brundage Michael22,Palmer Michael22,Kluetz Paul20,Stephens Richard23,Golub Robert M.24,Mitchell Sandra25,Groves Trish26,

Affiliation:

1. Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, England

2. Sydney Medical School, Faculty of Medicine and School of Psychology, Faculty of Science, University of Sydney, Sydney, Australia

3. Women’s College Research Institute, Department of Medicine, University of Toronto, Toronto, Ontario, Canada

4. Health Research Authority, London, England

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

6. Modus Outcomes, Lyon, France

7. University of Toronto, Toronto, Ontario, Canada

8. Panel on Research Ethics, Toronto, Ontario, Canada

9. Medicines and Healthcare Products Regulatory Agency, London, England

10. Evidera, Bethesda, Maryland

11. University of Washington, Seattle

12. University of Oxford, Oxford, England

13. University of North Carolina, Chapel Hill

14. University of Leeds, Leeds, England

15. Patient Partner, Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, England

16. University of Warwick, Coventry, England

17. University of Bristol, Bristol, England

18. Janssen Global Services, Johnson and Johnson, High Wycombe, England

19. Merck Sharp & Dohme Corporation, Whitehouse Station, New Jersey

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

21. Patient-Centered Outcomes Research Institute, Washington, DC

22. Queen’s University, Kingston, Ontario, Canada

23. National Cancer Research Institute Consumer Forum, London, England

24. The JAMA Network, Chicago, Illinois

25. National Cancer Institute, Rockville, Maryland

26. British Medical Journal, London, England

Publisher

American Medical Association (AMA)

Subject

General Medicine

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