University of Worcester Worcester Research and Publications

Listening to the patient voice adds value to cancer clinical trials.

Brundage, M. D., Crossnohere, N. L., O'Donnell, J., Cruz Rivera, S., Wilson, R., Wu, A.W., David, M., Kyte, Derek ORCID:, Reeve, B.B., Gilbert, A., Chen, R. C., Calvert, M. J. and Snyder, C. (2022) Listening to the patient voice adds value to cancer clinical trials. Journal of the National Cancer Institute, 114 (10). pp. 1323-1332. ISSN 1460-2105

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Randomized clinical trials are critical for evaluating the safety and efficacy of interventions in oncology and informing regulatory decisions, practice guidelines, and health policy. Patient-reported outcomes (PROs) are increasingly used in randomized trials to reflect the impact of receiving cancer therapies from the patient perspective and can inform evaluations of interventions by providing evidence that cannot be obtained or deduced from clinicians' reports or from other biomedical measures. This commentary focuses on how PROs add value to clinical trials by representing the patient voice. We employed two previously published descriptive frameworks (addressing how PROs are used in clinical trials and how PROs have an impact, respectively) and selected nine clinical trial publications that illustrate the value of PROs according to the framework categories. These include three trials where PROs were a primary trial endpoint, three trials where PROs as secondary endpoints supported the primary endpoint, and three trials where PROs as secondary endpoints contrast the primary endpoint findings in clinically important ways. The nine examples illustrate that PROs add valuable data to the care and treatment context by informing future patients about how they may feel and function on different treatments and by providing clinicians with evidence to support changes to clinical practice and shared decision-making. Beyond the patient and clinician, PROs can enable administrators to consider the cost-effectiveness of implementing new interventions, and contribute vital information to policy-makers, health technology assessors, and regulators. These examples provide a strong case for the wider implementation of PROs in cancer trials. [Abstract copyright: © The Author(s) (2022). Published by Oxford University Press.]

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This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (, which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact

Divisions: College of Health, Life and Environmental Sciences > School of Allied Health and Community
Copyright Info: © The Author(s) 2022. Published by Oxford University Press
SWORD Depositor: Prof. Pub Router
Depositing User: Prof. Pub Router
Date Deposited: 27 Oct 2022 15:46
Last Modified: 27 Oct 2022 15:46

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