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癌症患者与非癌症患者参与临床试验的意愿及影响因素调查

Survey of willingness to participate in clinical trials and influencing factors among cancer and non-cancer patients.

作者信息

King Teck Long, Tan Shirin Hui, Tan Shirley Siang Ning, Lai Wei Hong, Bujang Mohamad Adam, Voon Pei Jye

机构信息

Clinical Research Centre Sarawak General Hospital, Institute for Clinical Research, National Institutes of Health, Ministry of Health, Kuching, Malaysia.

Department of Pharmacy, Sarawak General Hospital, Ministry of Health, Kuching, Malaysia.

出版信息

Sci Rep. 2025 Jan 10;15(1):1626. doi: 10.1038/s41598-024-83626-7.

Abstract

Despite the expanding landscape of clinical trials, there is a lack of study concerning Malaysian patients' participation and perspectives. This study addresses these gaps by assessing patients' willingness, knowledge, perceptions, confidence, and religious barriers related to clinical trial participations at Sarawak General Hospital. We conducted a cross-sectional survey from March to September 2022 on 763 cancer and non-cancer patients. We collected patients' responses and calculated scores for willingness to participate (40.5/100), knowledge (29.9/100), perceived benefits (66.5/100) and risks (72.4/100) of participations, confidence in clinical trial conducts (66.3/100), and religious barriers (49.8/100). The higher scores indicated greater willingness, better knowledge, stronger perceptions of benefits and risk, increased confidence, and stronger religious barriers. Cancer patient demonstrated significantly greater willingness for trials involving new drugs (31.9/100 vs. 27.4/100, p = 0.021) but slightly higher religious barriers compared to non-cancer cohort (51.4/100 vs. 48.3/100, p = 0.006). Multivariable logistic regression identified female gender, unemployment, poor knowledge, low perceived benefits, high perceived risks, and low confidence as significant factors associated with reduced willingness to participate (p < 0.05). This study underscores the challenges in engaging Malaysian patients in clinical trials, particularly in Sarawak, emphasising the need for targeted strategies to raise awareness, effective communication, and enhancing public confidence in clinical trials.

摘要

尽管临床试验的规模在不断扩大,但针对马来西亚患者参与情况和观点的研究却很匮乏。本研究通过评估砂拉越总医院患者参与临床试验的意愿、知识、认知、信心和宗教障碍来填补这些空白。我们在2022年3月至9月对763名癌症和非癌症患者进行了横断面调查。我们收集了患者的回答,并计算了参与意愿(40.5/100)、知识水平(29.9/100)、感知益处(66.5/100)和风险(72.4/100)、对临床试验开展的信心(66.3/100)以及宗教障碍(49.8/100)的得分。得分越高表明意愿越强、知识越丰富、对益处和风险的认知越强、信心越高以及宗教障碍越强。癌症患者对涉及新药的试验表现出显著更高的意愿(31.9/100对27.4/100,p = 0.021),但与非癌症患者群体相比,宗教障碍略高(51.4/100对48.3/100,p = 0.006)。多变量逻辑回归分析确定,女性、失业、知识水平低、感知益处低、感知风险高和信心低是与参与意愿降低相关的显著因素(p < 0.05)。本研究强调了让马来西亚患者参与临床试验所面临的挑战,尤其是在砂拉越,强调需要有针对性的策略来提高认识、进行有效沟通并增强公众对临床试验的信心。

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