International perspectives on suboptimal patient‐reported outcome trial design and reporting in cancer clinical trials: A qualitative study-Reference-Cited by-同舟云学术

International perspectives on suboptimal patient‐reported outcome trial design and reporting in cancer clinical trials: A qualitative study

Published:2021-07-05 Issue:16 Volume:10 Page:5475-5487
ISSN:2045-7634
Container-title:Cancer Medicine
language:en
Short-container-title:Cancer Med

Author:

Retzer Ameeta¹²^ORCID,Calvert Melanie¹²³⁴,Ahmed Khaled¹,Keeley Thomas¹⁵,Armes Jo⁶⁷⁸,Brown Julia M.⁹,Calman Lynn⁶¹⁰,Gavin Anna⁶¹¹,Glaser Adam W.⁶¹²,Greenfield Diana M.⁶¹³,Lanceley Anne⁶¹⁴,Taylor Rachel M.⁶¹⁵^ORCID,Velikova Galina¹²,Brundage Michael¹⁶,Efficace Fabio¹⁷^ORCID,Mercieca‐Bebber Rebecca¹⁸¹⁹^ORCID,King Madeleine T.¹⁸,Kyte Derek¹⁴⁶²⁰

Affiliation:

1. Centre for Patient‐Reported Outcomes Research Institute of Applied Health Research University of Birmingham Birmingham UK

2. NIHR ARC West Midlands London UK

3. Birmingham Health Partners Centre for Regulatory Science and Innovation University of Birmingham Birmingham UK

4. NIHR Birmingham Biomedical Research Centre and NIHR Surgical Reconstruction and Microbiology Research Centre University Hospitals Birmingham NHS Foundation Trust and University of Birmingham Birmingham UK

5. GlaxoSmithKline (formerly of CPROR, University of Birmingham Birmingham UK

6. UK National Cancer Research Institute (NCRI) Psychosocial Oncology and Survivorship CSG Subgroup: Understanding and Measuring the Consequences of Cancer and its Treatment London UK

7. School of Health Sciences University of Surrey Guildford UK

8. NIHR ARC Kent London UK

9. Clinical Trials Research Unit University of Leeds Leeds UK

10. Macmillan Survivorship Research Group Health Sciences University of Southampton Southampton UK

11. N. Ireland Cancer Registry Centre for Public Health Queens University Belfast UK

12. Leeds Institute of Medical Research at St James’sUniversity of Leeds Leeds UK

13. Sheffield Teaching Hospital NHS Foundation Trust and University of Sheffield Sheffield UK

14. UCL Elizabeth Garrett Anderson Institute for Women’s Health Medical School Building University College London London UK

15. Centre for Nurse, Midwife and Allied Health Profession Led Research (CNMAR University College London Hospitals NHS Foundation Trust London UK

16. Queen’s Department of Oncology Queen’s Cancer Research Institute Kingston ON Canada

17. Italian Group for Adult Hematologic Diseases (GIMEMA Health Outcomes Research Unit Rome Italy

18. School of Psychology University of Sydney Sydney NSW Australia

19. University of SydneyNHMRC Clinical Trials Centre Sydney NSW Australia

20. School of Applied Health & Community University of Worcester Worcester UK

Funder

Macmillan Cancer Support

Publisher

Wiley

Subject

Cancer Research,Radiology, Nuclear Medicine and imaging,Oncology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cam4.4111

Reference40 articles.

1. Food and Drug Administration.Guidance for Industry: Patient‐Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims 2009.https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/patient‐reported‐outcome‐measures‐use‐medical‐product‐development‐support‐labeling‐claims

2. Toward Patient-Centered Drug Development in Oncology

3. Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada

4. The Use of Patient-reported Outcomes (PRO) Within Comparative Effectiveness Research

5. European Medicines Agency.Appendix 2 to the Guideline on the Evaluation of Anticancer Medicinal Products in Man. The Use of Patient‐Reported Outcome (PRO) Measures in Oncology Studies 2016.https://www.ema.europa.eu/en/documents/other/appendix‐2‐guideline‐evaluation‐anticancer‐medicinal‐products‐man_en.pdf

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