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Volume 12 Issue 6
Nov.  2021
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Article Navigation >  Medical Journal of Peking Union Medical College Hospital  > 2021  >  12(6): 849-853
XIE Jing, WANG Huanling. Patient-centric Clinical Trials: A New Paradigm for Drug Development[J]. Medical Journal of Peking Union Medical College Hospital, 2021, 12(6): 849-853. doi: 10.12290/xhyxzz.2021-0056
Citation: XIE Jing, WANG Huanling. Patient-centric Clinical Trials: A New Paradigm for Drug Development[J]. Medical Journal of Peking Union Medical College Hospital, 2021, 12(6): 849-853. doi: 10.12290/xhyxzz.2021-0056
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Patient-centric Clinical Trials: A New Paradigm for Drug Development

doi: 10.12290/xhyxzz.2021-0056
  • 1.

    Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China

  • 2.

    Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China

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  • Corresponding author: WANG Huanling  Tel: 86-10-69158360, E-mail: wanghuanling@pumch.cn
  • Received Date: 2021-01-18
  • Accepted Date: 2021-04-22
    • Available Online: 2021-09-15
  • Publish Date: 2021-11-30
    Abstract
  • With the acceleration of innovative drugs launched in the market, clinical trials have become increasingly complex and costly. Integration of patients' perspective and engagement into the clinical research process is essential to the success of the trials, which leads to the emergence of the concept of patient-centric clinical trials. Compared to the conventional paradigm of clinical trials, patient-centric clinical trials have the potential to increase the feasibility of study protocol, to speed recruitment and execution, and to promote the success of trials. It calls for the institutions and investigators of clinical trials to be aware of and adapt to patient-centric initiatives. In this article, we highlight technologies and actions that can be used to enhance patients' engagement in the entire process of drug development, covering protocol development, trial conduction, and result publication.
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    • References(20)
  • [1] Sharma NS. Patient centric approach for clinical trials: Current trend and new opportunities[J]. Perspect Clin Res, 2015, 6: 134-138. doi:  10.4103/2229-3485.159936
    [2] Smith MY, Benattia I. The Patient's Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization[J]. Drug Saf, 2016, 39: 779-785. doi:  10.1007/s40264-016-0426-9
    [3] Dockendorf MF, Hansen BJ, Bateman KP, et al. Digitally Enabled, Patient-Centric Clinical Trials: Shifting the Drug Development Paradigm[J]. Clin Transl Sci, 2021, 14: 445-459. doi:  10.1111/cts.12910
    [4] Babiker HM, Davis L, Larson K, et al. A Multidisciplinary Evaluation of Barriers to Enrolling Cancer Patients into Early Phase Clinical Trials: Challenges and Patient-centric Recommendations[J]. Expert Opin Investig Drugs, 2019, 28: 675-686. doi:  10.1080/13543784.2019.1646726
    [5] Patalano F, Gutzwiller FS, Shah B, et al. Gathering Structured Patient Insight to Drive the PRO Strategy in COPD: Patient-Centric Drug Development from Theory to Practice[J]. Adv Ther, 2020, 37: 17-26. doi:  10.1007/s12325-019-01134-x
    [6] Desai A, Warner J, Kuderer N, et al. Crowdsourcing a crisis response for COVID-19 in oncology[J]. Nat Cancer, 2020: 1-4. doi:  10.1038/s43018-020-0065-z.[Epubahead of print].
    [7] Day S, Mathews A, Blumberg M, et al. Broadening community engagement in clinical research: Designing and assessing a pilot crowdsourcing project to obtain community feedback on an HIV clinical trial[J]. Clin Trials, 2020, 17: 306-313. doi:  10.1177/1740774520902741
    [8] Leiter A, Sablinski T, Diefenbach M, et al. Use of Crowdsourcing for Cancer Clinical Trial Development[J]. J Natl Cancer Inst, 2014, 106: dju258. http://www.onacademic.com/detail/journal_1000036697570210_e183.html
    [9] Lee YJ, Arida JA, Donovan HS. The application of crowdsourcing approaches to cancer research: a systematic review[J]. Cancer Med, 2017, 6: 2595-2605. doi:  10.1002/cam4.1165
    [10] P Bateman K. The development of patient-centric sampling as an enabling technology for clinical trials[J]. Bioanalysis, 2020, 12: 971-976. doi:  10.4155/bio-2020-0075
    [11] James CA, Barfield MD, Maass KF, et al. Will patient-centric sampling become the norm for clinical trials after COVID-19?[J]. Nat Med, 2020, 26: 1810. doi:  10.1038/s41591-020-01144-1
    [12] Lamberti MJ, Awatin J. Mapping the Landscape of Patient-centric Activities Within Clinical Research[J]. Clin Ther, 2017, 39: 2196-2202. doi:  10.1016/j.clinthera.2017.09.010
    [13] U.S. Department of Health and Human Services Food and Drug Administration. Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. Draft Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders[EB/OL]. [2021-1-11]. https://www.fda.gov/media/139088/download.
    [14] Annapureddy N, Devilliers H, Jolly M. Patient-reported outcomes in lupus clinical trials with biologics[J]. Lupus, 2016, 25: 1111-1121. doi:  10.1177/0961203316652494
    [15] 冯仁田, 杨志清. 欧美临床试验文件中通俗化语言的应用[J]. 中国新药与临床杂志, 2021, 40: 356-361. https://www.cnki.com.cn/Article/CJFDTOTAL-XYYL202105007.htm

    Feng RT, Yang ZQ. Application of plain language in clinical study documents in European and American[J]. Zhongguo Xinyao Yu Linchuang Zazhi, 2021, 40: 356-361. https://www.cnki.com.cn/Article/CJFDTOTAL-XYYL202105007.htm
    [16] Richards DP, Birnie KA, Eubanks K, et al. Guidance on authorship with and acknowledgement of patient partners in patient-oriented research[J]. Res Involv Engagem, 2020, 6: 38. doi:  10.1186/s40900-020-00213-6
    [17] Arnstein L, Wadsworth AC, Yamamoto BA, et al. Patient involvement in preparing health research peer-reviewed publications or results summaries: a systematic review and evidence-based recommendations[J]. Res Involv Engagem, 2020, 6: 34. doi:  10.1186/s40900-020-00190-w
    [18] Li CC, Dockendorf M, Kowalski K, et al. Population PK Analyses of Ubrogepant (MK-1602), a CGRP Receptor Antagonist: Enriching In-Clinic Plasma PK Sampling With Outpatient Dried Blood Spot Sampling[J]. J Clin Pharmacol, 2018, 58: 294-303. doi:  10.1002/jcph.1021
    [19] Faulkner M, Alikhaani J, Brown L, et al. Exploring Meaningful Patient Engagement in ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness)[J]. Med Care, 2018, 56: S11-S15. doi:  10.1097/MLR.0000000000000949
    [20] Marquis-Gravel G, Robertson H, Jones WS, et al. Streamlining the institutional review board process in pragmatic randomized clinical trials: challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial[J]. Trials, 2021, 22: 90. doi:  10.1186/s13063-021-05026-w
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