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

Ameeta Retzer^{1

2}, Olalekan Lee Aiyegbusi^{1

2

3

4}, Anna Rowe^{3

5}, Philip N Newsome^{3

6}, Jessica Douglas-Pugh⁵, Sheeba Khan^{3

6

7}, Saloni Mittal⁸, Roger Wilson⁹, Daniel O'Connor¹⁰, Lisa Campbell¹⁰, Sandra A Mitchell¹¹, Melanie Calvert^{12

13

14

15

16

17}

Affiliations

¹ Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
² National Institute for Health Research Applied Research Centre West Midlands, University of Birmingham, Birmingham, UK.
³ National Institute for Health Research Birmingham Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
⁴ Birmingham Health Partners Centre for Regulatory Science and Innovation, Birmingham, UK.
⁵ Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.
⁶ Centre for Liver and Gastrointestinal Research, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.
⁷ Liver Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
⁸ University of Birmingham, Birmingham, UK.
⁹ NCRI Consumer Forum National Cancer Research Institute, London, UK.
¹⁰ Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
¹¹ Outcomes Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA.
¹² Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK. m.calvert@bham.ac.uk.
¹³ National Institute for Health Research Applied Research Centre West Midlands, University of Birmingham, Birmingham, UK. m.calvert@bham.ac.uk.
¹⁴ National Institute for Health Research Birmingham Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. m.calvert@bham.ac.uk.
¹⁵ Birmingham Health Partners Centre for Regulatory Science and Innovation, Birmingham, UK. m.calvert@bham.ac.uk.
¹⁶ National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham, UK. m.calvert@bham.ac.uk.
¹⁷ UK SPINE, University of Birmingham, Birmingham, UK. m.calvert@bham.ac.uk.

PMID: 35039659
DOI: 10.1038/s41591-021-01648-4

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

Ameeta Retzer et al. Nat Med. 2022 Jan.

. 2022 Jan;28(1):18-20.

doi: 10.1038/s41591-021-01648-4.

Authors

Affiliations

¹ Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
² National Institute for Health Research Applied Research Centre West Midlands, University of Birmingham, Birmingham, UK.
³ National Institute for Health Research Birmingham Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
⁴ Birmingham Health Partners Centre for Regulatory Science and Innovation, Birmingham, UK.
⁵ Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.
⁶ Centre for Liver and Gastrointestinal Research, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.
⁷ Liver Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
⁸ University of Birmingham, Birmingham, UK.
⁹ NCRI Consumer Forum National Cancer Research Institute, London, UK.
¹⁰ Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
¹¹ Outcomes Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD, USA.
¹² Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK. m.calvert@bham.ac.uk.
¹³ National Institute for Health Research Applied Research Centre West Midlands, University of Birmingham, Birmingham, UK. m.calvert@bham.ac.uk.
¹⁴ National Institute for Health Research Birmingham Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. m.calvert@bham.ac.uk.
¹⁵ Birmingham Health Partners Centre for Regulatory Science and Innovation, Birmingham, UK. m.calvert@bham.ac.uk.
¹⁶ National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham, UK. m.calvert@bham.ac.uk.
¹⁷ UK SPINE, University of Birmingham, Birmingham, UK. m.calvert@bham.ac.uk.

PMID: 35039659
DOI: 10.1038/s41591-021-01648-4

No abstract available

PubMed Disclaimer

References

1. US Food and Drug Administration (FDA). The Drug Development Process–Step 3: Clinical Research; https://www.fda.gov/patients/drug-development-process/step-3-clinical-re... (FDA, 2018).
1. Coleman, R. L. et al. Oncology 99, 444–453 (2021). - DOI
1. Basch, E. & Dueck, A. C. Exp. Opin. Drug Discov. 11, 753–758 (2016). - DOI
1. Fiteni, F. et al. BMC Cancer 19, 361 (2019). - DOI
1. Kirkham, J. J. et al. PLoS Med. 14, e1002447 (2017). - DOI

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions

Grants and funding

25354/CRUK_/Cancer Research UK/United Kingdom

LinkOut - more resources

Full Text Sources
- Nature Publishing Group
Medical
- MedlinePlus Health Information

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Affiliations

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

Authors

Affiliations

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical