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The application of qualitative research and mixed methods research in patient involvement in drug development
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Hong-ling CHU1, 2, Yan XU3, Sheng HAN4, Li-bo ZHAO5, Nan LI2, Li-yuan TAO2, Lin ZENG2, Lin ZHUO2, Ya-hong CHEN6, Yi-ming ZHAO2, Hai-yan LI1, 3, Si-yan ZHAN2, 7
Chinese Journal of New Drugs | 2023, 32(14) : 1392 - 1397
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Chinese Journal of New Drugs | 2023, 32(14): 1392-1397
The application of qualitative research and mixed methods research in patient involvement in drug development
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Hong-ling CHU1, 2, Yan XU3, Sheng HAN4, Li-bo ZHAO5, Nan LI2, Li-yuan TAO2, Lin ZENG2, Lin ZHUO2, Ya-hong CHEN6, Yi-ming ZHAO2, Hai-yan LI1, 3, Si-yan ZHAN2, 7
Affiliations
  • 1Department of Cardiovascular, Peking University Third Hospital, Beijing 100191, China
  • 2Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing 100191, China
  • 3Drug Clinical Trial Institute, Peking University Third Hospital, Beijing 100191, China
  • 4Department of Pharmacy Management and Clinical Pharmacy, Peking University, Beijing 100191, China
  • 5Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China
  • 6Department of Respiratory and Critical Care Medicine, Peking University Third Hospital, Beijing 100191, China
  • 7School of Public Health, Peking University, Beijing 100191, China
Published: 2023-07-30
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Patient engagement in drug development is a vital part of patient-centered drug development, and its value and implementation have been recognized and actively explored by leading countries or regions in the field of medicine all over the world. Since November 2021, the Center for Drug Evaluation has issued six guidelines or drafts for patient-centered drug development. Patients provide suggestions and feedback in time through deep participating in the drug development, while collecting and analyzing the information require scientific research methods to ensure the quality of patient data and the rigor and transparency of reports. Qualitative or mixed-methods research is a scientific research method suitable for patients open information collection, analysis, and reporting. However, these two methods may not be widely recognized in the field of drug development. Therefore, this paper briefly introduces these two methods and their application in patient involvement in drug development, aiming to improve the quality of related research.

patient involvement  /  drug development  /  qualitative research  /  mixed-methods research
Hong-ling CHU, Yan XU, Sheng HAN, Li-bo ZHAO, Nan LI, Li-yuan TAO, Lin ZENG, Lin ZHUO, Ya-hong CHEN, Yi-ming ZHAO, Hai-yan LI, Si-yan ZHAN. The application of qualitative research and mixed methods research in patient involvement in drug development[J]. Chinese Journal of New Drugs, 2023 , 32 (14) : 1392 -1397 .
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  • Online Date：2026-03-05
  • Published：2023-07-30
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History
  • Accepted：2022-11-01
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Affiliations
    1Department of Cardiovascular, Peking University Third Hospital, Beijing 100191, China
    2Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing 100191, China
    3Drug Clinical Trial Institute, Peking University Third Hospital, Beijing 100191, China
    4Department of Pharmacy Management and Clinical Pharmacy, Peking University, Beijing 100191, China
    5Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China
    6Department of Respiratory and Critical Care Medicine, Peking University Third Hospital, Beijing 100191, China
    7School of Public Health, Peking University, Beijing 100191, China
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