云南省患者临床试验的参与意愿影响因素分析及宣教建议

作者

陈琳昆明医科大学第二附属医院作者
赵慧佳昆明医科大学第二附属医院作者
王楹涵昆明医科大学第二附属医院作者
钱懿轶昆明医科大学第二附属医院作者
周元芳昆明医科大学第二附属医院作者

DOI:

https://doi.org/10.71411/jyyjx.2025.v1i7.802

关键词:

临床试验, 患者教育, 参与意愿, 云南省

摘要

提升患者参与意愿对保障临床试验效率和受试群体代表性具有关键作用。为了解云南省患者参与临床试验意愿的影响因素，并制定个性化患者教育策略，本研究采用横断面设计，以2024 年云南省某三甲医院就诊患者为研究对象进行问卷调查。最终纳入分析的412 份有效问卷中，患者总体参与意愿为84.2%（n=347），少数民族患者占比为20.9%（n=86）。Logistic 回归分析显示，患者参与意愿与其民族背景无显著相关性，而与临床试验参与经历、中等及以上认知水平呈正相关，与已婚、离异或丧偶状态呈负相关。患者参与临床试验的主要动机为“推动科学进步”与“潜在治疗收益”，主要担忧为“不良反应风险”。患者教育是提升临床试验参与意愿的关键环节，后续宣教方案的设计应紧密结合患者的参与动机与主要顾虑，以提高教育的针对性和有效性。

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作者简介

陈琳，昆明医科大学第二附属医院

陈琳，主管药师，中国科学院大学药理学硕士。现就职于昆明医科大学第二附属医院科研部临床研究中心。
赵慧佳，昆明医科大学第二附属医院

赵慧佳，统计师，四川大学流行病与统计学硕士。现就职于昆明医科大学第二附属医院科研部临床研究中心。
王楹涵，昆明医科大学第二附属医院

王楹涵，主管医师，中山大学流行病与统计学硕士。现就职于昆明医科大学第二附属医院科研部临床研究中心。
钱懿轶，昆明医科大学第二附属医院

钱懿轶，副主任药师，副教授，药理学硕士。现就职于昆明医科大学第二附属医院科研部临床研究中心。
周元芳，昆明医科大学第二附属医院

周元芳，主管药师，昆明医科大学第二附属医院药理学硕士，现就职于昆明医科大学第二附属医院科研部临床研究中心。

参考

[1] Chihara, D., LinR, Flowers, C. R., et al. Early drug development in solid tumours: analysis of National Cancer Institute-sponsored phase 1 trials[J]. Lancet, 2022, 400(10351): 512-521.

[2] Lynce, F., Blackburn, M. J., Cai, L., et al. Characteristics and outcomes of breast cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase I clinical trials[J]. Breast Cancer Res Treat, 2018, 168(1): 35-41.

[3] Huynh, M. M., Pambid, M. R., Jayanthan, A., et al. The dawn of targeted therapies for triple negative breast cancer (TNBC): a snapshot of investigational drugs in phase I and II trials[J]. Expert Opin Investig Drugs, 2020, 29(11): 1199-1208.

[4] Mcdonald, A. M., Knight, R. C., Campbell, M. K., et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies[J]. Trials, 2006, 7: 9.

[5] Walters, S. J., Bonacho Dos Anjos Henriques-Cadby, I., Bortolami, O., et al. Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme[J]. BMJ Open, 2017, 7(3): e015276.

[6] Ross, M. W., Jeffords, K., Gold, J. Reasons for entry into and understanding of HIV/AIDS clinical trials: a preliminary study[J]. AIDS Care, 1994, 6(1): 77-82.

[7] Clark, L. T., Watkins, L., Pina, I. L, et al. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers[J]. Curr Probl Cardiol, 2019, 44(5): 148-172.

[8] Shavers, V. L., Lynch, C. F., Burnmeister, L. F. Racial differences in factors that influence the willingness to participate in medical research studies[J]. Ann Epidemiol, 2002, 12(4): 248-256.

[9] Rajakumar, K., Thomas, S. B., Musa, D., et al. Racial differences in parents' distrust of medicine and research[J]. Arch Pediatr Adolesc Med, 2009, 163(2): 108-114.

[10] Nze, C., Herrera, A. F. New strategies for enhancing enrollment of underrepresented minorities in lymphoma clinical trials[J]. Blood Adv, 2025, 9(4): 774-782.

[11] Bass, S. B., D'avanzo, P., Alhajji, M., et al. Exploring the Engagement of Racial and Ethnic Minorities in HIV Treatment and Vaccine Clinical Trials: A Scoping Review of Literature and Implications for Future Research[J]. AIDS Patient Care STDS, 2020, 34(9): 399-416.

[12] 黄慧瑶, 樊琦, 房虹, 等. 肿瘤患者临床试验接受意愿及相关原因分析[J]. 中国肺癌杂志, 2020, 23(01): 41-49.

[13] 曹羽明, 曹越, 徐影, 等. 潜在受试者对药物临床试验认知的调查[J]. 医药导报, 2017, 36(02): 226-230.

[14] 赵娜萍, 高越, 王昊, 等. 公众对健康受试者认知度和参与意愿的调查[J]. 医学信息, 2024, 37(10): 50-57.

[15] 吴清, 孙超, 吴大维, 等. 肿瘤受试者对以患者为中心的药物临床试验的参与意愿及其影响因素调查[J]. 肿瘤药学, 2024, 14(06): 653-661.

[16] Liang, J. E., Liang, M. Y., Zhang, E. E., et al. Factors influencing willingness to participate in ophthalmic clinical trials and strategies for effective recruitment[J]. International Journal of Ophthalmology(English edition), 2024, 17(1): 157-163.

[17] Nievaard, M. A., De Vos, R., De Haes, J. C., et al. Reasons why patients do or do not participate in clinical trials; a systemic review of the literature[J]. Ned Tijdschr Geneeskd, 2004, 148(4): 186-190.

[18] Sheridan, R., Martin-Kerry, J., Hudson, J., et al. Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators[J]. Trials, 2020, 21(1): 259.

[19] 梁梦音, 梁嘉恩, 张恩恩, 等. 国内临床试验参与意愿分析及招募启示[J]. 全科护理, 2024, 22(03): 435-438.

[20] Wang, L., Zhang, R., Liu J., et al. An online survey on public awareness of drug clinical trials in inland cities of northern China[J]. Front Public Health, 2024, 12: 1276536.

[21] 李越, 杨玉静, 张晶. 老年慢性病患者参与药物临床试验意愿的医学伦理观念及影响因素[J]. 中国老年学杂志, 2024, 44(13): 3307-3310.

[22] 邢淑君, 陈鹤方, 胡梦蝶, 等. 肿瘤患者参与药物临床试验现状及影响因素研究[J]. 中国新药杂志, 2022, 31(12): 1201-1208.

[23] Abu Farha, R., Alzoubi, K. H., Khabour, O. F., et al. Factors Influencing Public Knowledge and Willingness to Participate in Biomedical Research in Jordan: A National Survey[J]. Patient Prefer Adherence, 2020, 14: 1373-1379.

[24] Wei, L. S., Izaguirre Germain, M. P., Caruso, D. Patients' Predisposition to Participate in Clinical Trials at Hospital: A Cross-Sectional Study[J]. Rev Esp Geriatr Gerontol, 2025, 60(1): 101536.

[25] Larussa, T., Suraci, E., Marasco, R., et al. Barriers and Facilitators in Conducting Clinical Trials in Inflammatory Bowel Disease: A Monocentric Italian Survey[J]. Rev Recent Clin Trials, 2020, 15(2): 137-144.

[26] Lee, J. J., Kim, D. H., Jang, Y. E., et al. The attitude toward xenocorneal transplantation in wait-listed subjects for corneal transplantation in Korea[J]. Xenotransplantation, 2014, 21(1): 25-34.

[27] Lara, P. N., J R., Paterniti, D. A., Chiechi, C., et al. Evaluation of factors affecting awareness of and willingness to participate in cancer clinical trials[J]. J Clin Oncol, 2005, 23(36): 9282-9289.

[28] Liu, H. E., Li, M. C. Factors influencing the willingness to participate in medical research: a nationwide survey in Taiwan region[J]. PeerJ, 2018, 6: e4874.

[29] Ratra, D., Sathishkumar, R. S., Ratra, A. Increasing awareness and attitude toward clinical trials[J]. Indian J Ophthalmol, 2024, 72(7): 1071-1072.

[30] Godskesen, T., Nygren, P., Nordin, K., et al. Phase 1 clinical trials in end-stage cancer: patient understanding of trial premises and motives for participation[J]. Support Care Cancer, 2013, 21(11): 3137-3142.

[31] Igwe E, Woodburn, J., Davolos, J., et al. Patient perceptions and willingness to participate in clinical trials[J]. Gynecol Oncol, 2016, 142(3): 520-524.