健康受试者参加Ⅰ期临床试验动机的人群差异性调查分析

Analysis on Population Differences in Motivation of Healthy Subjects to Participate in Phase Ⅰ Clinical Trials

目的 了解不同人群参加I期临床试验动机的差异性,为研究机构健康受试者的招募与管理提供建议,以期提高临床试验质量,保护受试者权益。方法 对2020年至2021年北京某三甲医院正在开展的I期临床试验健康受试者及社区潜在受试者进行问卷调查,运用SAS 9.2软件对资料进行统计分析。结果I期病房受试者与社区潜在受试者在人口社会学特征、参加试验动机及参加试验动机的影响因素方面存在多个维度的差异。I期病房受试者更关注获得试验补偿、健康照顾、社会交往与交友,及家庭或朋友等对其参加试验的态度;社区潜在受试者更关注试验质量、未来潜在获益(为医疗事业作贡献)以及对自身健康和生活的影响。结论 研究机构应针对不同社会背景人群分层制定招募、知情同意、人员管理的制度及标准操作规程,从多方面关注受试者的心理、生理需求,以规范受试者管理,提高受试者参加试验依从性及临床试验质量,给予受试者更多的人文关怀和帮助。

Objective: To understand the differences in motivation of different groups to participate in phase I clinical trials, and to provide suggestions for the recruitment and management of healthy subjects in research institutions, so as to improve the quality of clinical trials and protect the subjects’ rights and interests. Methods: Questionnaire survey was conducted among healthy subjects and potential community subjects in phase I clinical trials being carried out in a tertiary A hospital in Beijing from 2020 to 2021. SAS 9.2 was used for statistical analysis of data. Results: There were many dimension differences between phase I ward subjects and community potential subjects in demographic and sociological characteristics, motivation to participate in the trials and influencing factors of motivation to participate in the experiment. Subjects in phase I ward paid more attention to the trial compensation, health care, social interaction and making friends, and the attitude of family or friends towards their participation in the trials. Community potential subjects were more concerned about trial quality, future potential benefits(contributing to the medical profession), and the impact on their own health and life. Conclusion: Research institutions should be aimed at different social background population stratification for recruitment, informed consent, personnel management system and the standard operating procedure, and pay attention to the subjects’ psychological and physiological needs from several aspects to standardize the management of subjects, improve the compliance of subjects to participate in the trial and the quality of clinical trials, and give more humanistic care and help to subjects.