The value of patient-reported outcomes in early phase clinical trials

Ameeta Retzer; Olalekan Lee Aiyegbusi; Anna Rowe; Philip Newsome; Jessica  Douglas-Pugh; Sheeba Khan; Saloni Mittal; Roger  Wilson; Daniel O'Connor; Lisa  Campbell; Sandra A Mitchell; Melanie Calvert

doi:10.1038/s41591-021-01648-4

The value of patient-reported outcomes in early phase clinical trials

Ameeta Retzer, Olalekan Lee Aiyegbusi, Anna Rowe, Philip Newsome, Jessica Douglas-Pugh, Sheeba Khan, Saloni Mittal, Roger Wilson, Daniel O'Connor, Lisa Campbell, Sandra A Mitchell, Melanie Calvert^*

^*Corresponding author for this work

Research output: Contribution to journal › Comment/debate › peer-review

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Original language	English
Pages (from-to)	18–20
Number of pages	3
Journal	Nature Medicine
Volume	28
Issue number	1
DOIs	https://doi.org/10.1038/s41591-021-01648-4
Publication status	Published - 17 Jan 2022

Bibliographical note

Funding Information:
We thank A. Filer, P. Trivedi, D. Chanouzas, S. Ghosh and A. Dueck for their advice and suggestions during this project. The author(s) disclose receipt of the following financial support for the research, authorship and/ or publication of this article: This work was supported by the National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, Midlands-Wales Advanced Therapies Treatment Centre (MW-ATTC) program grant from Innovate UK to a consortium of partners including Health Technology Wales, the Welsh Blood Service and the University of Birmingham (grant number: IUK: 104232) and Innovate UK (part of UK Research and Innovation) grant Patient-reported outcomes assessment to support accelerated access to advanced cell and gene therapies: PROmics (grant number: 104777). The funder was not involved in any aspect of the research work. O.L.A., A.R. and M.C. receive funding from the NIHR Applied Research Collaboration, West Midlands (ARC), and the Brain Tumour Charity. O.L.A, receives funding from the NIHR Birmingham Biomedical Research Centre (BRC, 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. MC is Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, Director of the Centre for Patient Reported Outcomes Research and is a National Institute for Health Research (NIHR) Senior Investigator. She receives funding from the NIHR, UK Research and Innovation (UKRI), NIHR Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre and UK SPINE at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Health Data Research UK, Innovate UK (part of UKRI), Macmillan Cancer Support, UCB, Gilead, Janssen and GSK Pharma. The views expressed in this article are those of the authors and not necessarily those of the NIHR, the Department of Health and Social Care or the MHRA.

ASJC Scopus subject areas

General Biochemistry,Genetics and Molecular Biology

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10.1038/s41591-021-01648-4

RetzerA2021value
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Patient-reported outcomes assessment to support accelerated access to advanced cell and gene therapies:PROmics
Calvert, M., Newsome, P., Kyte, D., Harding, R. & Rowe, A.
TECHNOLOGY STRATEGY BOARD
1/12/18 → 31/03/22
Project: Other Government Departments
Midland & Wales Advanced Therapy Treatment Centre (ATTC)
Newsome, P., Ghosh, S., Craddock, C., Calvert, M. & Filer, A.
TECHNOLOGY STRATEGY BOARD
1/03/18 → 31/03/22
Project: Other Government Departments

Cite this

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title = "The value of patient-reported outcomes in early phase clinical trials",

author = "Ameeta Retzer and Aiyegbusi, {Olalekan Lee} and Anna Rowe and Philip Newsome and Jessica Douglas-Pugh and Sheeba Khan and Saloni Mittal and Roger Wilson and Daniel O'Connor and Lisa Campbell and Mitchell, {Sandra A} and Melanie Calvert",

note = "Funding Information: We thank A. Filer, P. Trivedi, D. Chanouzas, S. Ghosh and A. Dueck for their advice and suggestions during this project. The author(s) disclose receipt of the following financial support for the research, authorship and/ or publication of this article: This work was supported by the National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, Midlands-Wales Advanced Therapies Treatment Centre (MW-ATTC) program grant from Innovate UK to a consortium of partners including Health Technology Wales, the Welsh Blood Service and the University of Birmingham (grant number: IUK: 104232) and Innovate UK (part of UK Research and Innovation) grant Patient-reported outcomes assessment to support accelerated access to advanced cell and gene therapies: PROmics (grant number: 104777). The funder was not involved in any aspect of the research work. O.L.A., A.R. and M.C. receive funding from the NIHR Applied Research Collaboration, West Midlands (ARC), and the Brain Tumour Charity. O.L.A, receives funding from the NIHR Birmingham Biomedical Research Centre (BRC, 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. MC is Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, Director of the Centre for Patient Reported Outcomes Research and is a National Institute for Health Research (NIHR) Senior Investigator. She receives funding from the NIHR, UK Research and Innovation (UKRI), NIHR Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre and UK SPINE at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Health Data Research UK, Innovate UK (part of UKRI), Macmillan Cancer Support, UCB, Gilead, Janssen and GSK Pharma. The views expressed in this article are those of the authors and not necessarily those of the NIHR, the Department of Health and Social Care or the MHRA.",

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AU - Aiyegbusi, Olalekan Lee

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AU - Khan, Sheeba

AU - Mittal, Saloni

AU - Wilson, Roger

AU - O'Connor, Daniel

AU - Campbell, Lisa

AU - Mitchell, Sandra A

AU - Calvert, Melanie

N1 - Funding Information: We thank A. Filer, P. Trivedi, D. Chanouzas, S. Ghosh and A. Dueck for their advice and suggestions during this project. The author(s) disclose receipt of the following financial support for the research, authorship and/ or publication of this article: This work was supported by the National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, Midlands-Wales Advanced Therapies Treatment Centre (MW-ATTC) program grant from Innovate UK to a consortium of partners including Health Technology Wales, the Welsh Blood Service and the University of Birmingham (grant number: IUK: 104232) and Innovate UK (part of UK Research and Innovation) grant Patient-reported outcomes assessment to support accelerated access to advanced cell and gene therapies: PROmics (grant number: 104777). The funder was not involved in any aspect of the research work. O.L.A., A.R. and M.C. receive funding from the NIHR Applied Research Collaboration, West Midlands (ARC), and the Brain Tumour Charity. O.L.A, receives funding from the NIHR Birmingham Biomedical Research Centre (BRC, 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. MC is Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, Director of the Centre for Patient Reported Outcomes Research and is a National Institute for Health Research (NIHR) Senior Investigator. She receives funding from the NIHR, UK Research and Innovation (UKRI), NIHR Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre and UK SPINE at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Health Data Research UK, Innovate UK (part of UKRI), Macmillan Cancer Support, UCB, Gilead, Janssen and GSK Pharma. The views expressed in this article are those of the authors and not necessarily those of the NIHR, the Department of Health and Social Care or the MHRA.

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The value of patient-reported outcomes in early phase clinical trials

Bibliographical note

ASJC Scopus subject areas

Access to Document

Projects

Patient-reported outcomes assessment to support accelerated access to advanced cell and gene therapies:PROmics

Midland & Wales Advanced Therapy Treatment Centre (ATTC)

Cite this