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Editorial
. 2021 Nov;14(6):695-697.
doi: 10.1007/s40271-021-00542-y. Epub 2021 Aug 2.

FDA Guidance on Assessment of Patient-Reported Outcomes in Cancer Trials: A Breath of Fresh Air or a Storm in a Teacup?

Ari Gnanasakthy  1
Affiliations
Editorial

FDA Guidance on Assessment of Patient-Reported Outcomes in Cancer Trials: A Breath of Fresh Air or a Storm in a Teacup?

Ari Gnanasakthy. Patient. 2021 Nov.
No abstract available

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References

    1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for industry: core patient-reported outcomes in cancer clinical trials. 2021. https://www.fda.gov/media/149994/download . Accessed 24 Jul 2021.
    1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, & Center for Devices and Radiological Health. Guidance for industry: patient-reported outcomes measures: use in medical product development to support labeling claims. 2009. https://www.fda.gov/media/77832/download . Accessed 26 July 2021.
    1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, & Center for Devices and Radiological Health. Guidance for industry: clinical trial endpoints for the approval of cancer drugs and biologics. 2018. https://www.fda.gov/media/71195/download . Accessed 24 Jul 2021.
    1. Kluetz PG, Slagle A, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, et al. Focusing on core patient-reported outcomes in cancer clinical trials: symptomatic adverse events, physical function, and disease-related symptoms. Clin Cancer Res. 2016;22(7):1553–8. - DOI
    1. Kluetz PG, Kanapuru B, Lemery S, Johnson LL, Fiero MH, Arscott K, et al. Informing the tolerability of cancer treatments using patient-reported outcome measures: summary of an FDA and critical path institute workshop. Value Health. 2018;21(6):742–7. - DOI

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