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Patient-reported outcomes in the regulatory approval of medical devices

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S.C.R., A.P.D. and M.J.C. conceived the idea for this article; S.C.R. developed the first draft; and all authors made substantial revisions and approved the final manuscript.

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Correspondence to Samantha Cruz Rivera.

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Competing interests

O.L.A. receives funding from the NIHR Birmingham Biomedical Research Centre, NIHR Applied Research Centre, West Midlands, at the University of Birmingham and University Hospitals Birmingham NHS Foundation, Innovate UK (part of UK Research and Innovation), Gilead Sciences Ltd. and Janssen Pharmaceuticals, Inc. O.L.A. declares personal fees from Gilead Sciences Ltd., GlaxoSmithKline (GSK) and Merck outside the submitted work. M.J.C. is director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, director of the Centre for Patient Reported Outcomes Research and a National Institute for Health Research (NIHR) Senior Investigator. M.J.C. receives funding from the NIHR Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre and NIHR ARC West Midlands at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Health Data Research UK, Innovate UK (part of UK Research and Innovation), Macmillan Cancer Support, UCB and GSK Pharma. M.J.C. has received personal fees from Astellas, Takeda, Merck, Daiichi Sankyo, Aparito Ltd., CIS Oncology, Glaukos, GSK and the Patient-Centered Outcomes Research Institute (PCORI) outside the submitted work. The other authors declare no competing interests. The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, the Department of Health and Social Care or the MHRA.

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Cruz Rivera, S., Dickens, A.P., Aiyegbusi, O.L. et al. Patient-reported outcomes in the regulatory approval of medical devices. Nat Med 27, 2067–2068 (2021). https://doi.org/10.1038/s41591-021-01546-9

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