Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).

@article{Gnanasakthy2016PatientReportedOL,
  title={Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).},
  author={A. Gnanasakthy and C. Demuro and M. Clark and E. Haydysch and E. Ma and V. Bonthapally},
  journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
  year={2016},
  volume={34 16},
  pages={
          1928-34
        }
}
  • A. Gnanasakthy, C. Demuro, +3 authors V. Bonthapally
  • Published 2016
  • Medicine
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
    • PURPOSE To review the use of patient-reported outcome (PRO) data in medical product labeling granted by the US Food and Drug Administration (FDA) for new molecular entities and biologic license applications by the FDA Office of Hematology and Oncology Products (OHOP) between January 2010 and December 2014, to elucidate challenges faced by OHOP for approving PRO labeling, and to understand challenges faced by drug manufacturers to include PRO end points in oncology clinical trials. METHODS FDA… CONTINUE READING
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    31 Citations
    Highly Influencial Citations
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    Methods Citations
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    31 Citations
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    References

    SHOWING 1-10 OF 24 REFERENCES
    A review of patient-reported outcome labels in the United States: 2006 to 2010.
    • 95
    Reasons for rejection of patient-reported outcome label claims: a compilation based on a review of patient-reported outcome use among new molecular entities and biologic license applications, 2006-2010.
    • 41
    • PDF
    Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.
    • 72
    • PDF
    Assessment of PRO label claims granted by the FDA as compared to the EMA (2006-2010).
    • 47
    • PDF
    End points and United States Food and Drug Administration approval of oncology drugs.
    • 447
    • PDF
    Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union
    • 20
    The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology.
    • 65
    Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe.
    • 60
    Patient-reported outcomes assessment in cancer trials: evaluating and enhancing the payoff to decision making.
    • 53
    Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).
    • 410