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Interpretation of the "Core Patient-reported Outcomes in Cancer Clinical Trials Guidance for Industry (draft)"
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Ming-rui LIU1, Mi YAO2, 3, Hui ZHOU4, Xiang GAO4, Gang YUAN5, 6
Chinese Journal of New Drugs | 2023, 32(7) : 719 - 723
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Chinese Journal of New Drugs | 2023, 32(7): 719-723
Interpretation of the "Core Patient-reported Outcomes in Cancer Clinical Trials Guidance for Industry (draft)"
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Ming-rui LIU1, Mi YAO2, 3, Hui ZHOU4, Xiang GAO4, Gang YUAN5, 6
Affiliations
  • 1School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou 510006, China
  • 2Department of General Practice, Peking University First Hospital, Beijing 100034, China
  • 3Department of General Practice, Peking University Health Science Center, Beijing 100191, China
  • 4Department of Pharmacy, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510080, China
  • 5Department of Geriatrics, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510080, China
  • 6Phase I Clinical Trial Center, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510080, China
Published: 2023-04-15
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The concept of patient-focused drug development has been paid increasing attention by researchers in China and abroad. Patient-reported outcome (PRO) has gradually become one of the endpoints in clinical trials. PRO provides health information directly from the patient and plays an important role in the clinical decision making by physicians. However, the use of PRO assessment and data interpretation in oncology clinical trials are still waiting for further improvement. The selection of core PRO indicators is critical to the consistency of PRO assessment criteria. In 2021, U.S. FDA issued the "Core Patient-Reported Outcomes in Cancer Clinical Trials Guidance for Industry (draft)" for drug development in cancer clinical trials, providing guidance for sponsors on core PRO collection, PRO assessment tool selection, and standardized trial design. This paper interprets the systematic assessment and application of core PRO in the guideline, helps practitioners of new drug clinical trials to further understand PRO and promotes the implement of PROs in new drug clinical trials in a good way.

cancer clinical trials  /  patient-reported outcomes  /  experimental design
Ming-rui LIU, Mi YAO, Hui ZHOU, Xiang GAO, Gang YUAN. Interpretation of the "Core Patient-reported Outcomes in Cancer Clinical Trials Guidance for Industry (draft)"[J]. Chinese Journal of New Drugs, 2023 , 32 (7) : 719 -723 .
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  • Online Date：2026-03-06
  • Published：2023-04-15
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History
  • Accepted：2022-09-29
Affiliations
    1School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou 510006, China
    2Department of General Practice, Peking University First Hospital, Beijing 100034, China
    3Department of General Practice, Peking University Health Science Center, Beijing 100191, China
    4Department of Pharmacy, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510080, China
    5Department of Geriatrics, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510080, China
    6Phase I Clinical Trial Center, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510080, China
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红菇属 Russula 17 8.13
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