摘要
目的 探讨健康受试者参加药物Ⅰ期临床试验动机及影响因素.方法 本研究为横断面研究,收集2020年6月—2021年8月北京地坛医院正在开展的药物Ⅰ期临床试验健康受试者进行问卷调查,最终纳入527人.根据参加试验的意愿分组,分类资料采用频数(%)描述,组间比较采用χ2或Fisher检验;符合正态分布的定量指标采用-x±s表示,组间比较采用t检验;非正态分布定量指标描述采用M(Q1,Q3)表示,组间比较采用秩和检验.资料多因素分析采用logistic回归分析,逐步回归法筛选变量.结果 单因素分析结果显示,人口社会学因素包括年龄、性别、家庭月收入、就业情况、婚姻状况、城镇职工医疗保险、健康状况、居住地、对试验了解程度、参加试验经历对于是否愿意参加临床试验的影响具有统计学意义(P均＜0.05).参加试验动机包括为医药事业做贡献、为其他患者未来使用药物带来帮助、得到较高的经济补偿、获得免费医疗照顾、获得社会交往,两组间动机差异具有统计学意义(P均＜0.05).试验动机影响因素统计结果显示试验操作(如抽血、穿刺活检、CT等检查)对身体造成的损害和担心被别人看不起或歧视降低受试者参加试验的意愿;试验病房管理水平及规范性、个人信息是否被保密、个人经济状况、试验提供的经济补偿标准、试验补偿款的发放速度增加受试者参加试验的意愿,组间差异具有统计学意义(P均＜0.05).多因素logistic回归分析结果显示年龄(OR=1.05,P=0.008)、为医药事业做贡献(OR=1.57,P=0.001)、为其他患者未来使用药物带来帮助(OR=1.99,P＜0.001)、得到较高的经济补偿(OR=1.40,P=0.012)、试验病房管理水平及规范性(OR=1.46,P=0.010)、个人信息是否被保密(OR=1.32,P=0.030)、试验补偿款的发放速度(OR=1.46,P=0.004),上述因素增加受试者参加试验的意愿;而试验操作(如抽血、穿刺活检、CT等检查)对身体造成的损害(OR=0.42,P＜0.001)、女性相对于男性(OR=0.41,P=0.004)降低受试者参加试验的意愿.结论 健康受试者除了关注获得试验补偿外,还有其他的利他、利己试验动机,如获得免费健康照顾、社会交往、为医药事业做贡献及为他人用药带来帮助等.试验风险、受试者年龄、性别、婚姻状况、试验经历、隐私保密及研究者能力及病房管理水平等影响受试者参加试验的动机.
Abstract
Objective To explore the motivation and influencing factors of healthy volunteers participating in phase Ⅰ clinical trials of medications.Methods This study was a cross-sectional study.A questionnaire survey was conducted among healthy volunteers participating in phase Ⅰ clinical trials of medications at the Beijing Ditan Hospital from June 2020 to August 2021,with a total of 527 participants included.Grouping was based on the willingness to participate in the trial,and descriptive statistics(%)were used for categorical data,with comparisons between groups conducted using the χ2 test or Fisher's exact test.For normally distributed quantitative variables,results were presented as (((xˉ)))±s,and comparisons between groups were performed using the independent sample t-test;non-normally distributed quantitative variables were described using M(Q1,Q3),and group comparisons were conducted using the Wilcoxon rank-sum test.Multivariable logistic regression analysis was used for data analysis,with variable selection performed using stepwise regression.Results Results of univariate analysis showed that demographic factors including age,gender,monthly family income,employment status,marital status,urban employee medical insurance,health status,residence,understanding of the trial,and trial experience had statistically significant effects on the willingness to participate in clinical trials(all P＜0.05).Motivations for trial participation,including contributing to medical research,helping future patients,receiving higher financial compensation,obtaining free medical care,and social interaction,showed statistically significant differences between groups(all P＜0.05).Statistical analysis of factors influencing trial motivation showed that concerns about physical harm from trial procedures(e.g.,blood draws,biopsies,CT scans)and fear of stigma or discrimination decreased willingness to participate in the trial.On the other hand,the level and standardization of trial ward management,confidentiality of personal information,personal financial status,compensation standards,and the speed of compensation disbursement increased willingness to participate(all P＜0.05).Multivariable logistic regression analysis revealed that age(OR=1.05,P=0.008),contributing to medical research(OR=1.57,P=0.001),helping future patients(OR=1.99,P＜0.001),receiving higher financial compensation(OR=1.40,P=0.012),trial ward management level and standardization(OR=1.46,P=0.010),confidentiality of personal information(OR=1.32,P=0.030),and speed of compensation disbursement(OR=1.46,P=0.004)increased the willingness of participants to join the trial,whereas concerns about physical harm from trial procedures(OR=0.42,P＜0.001)and being female(OR=0.41,P=0.004)decreased willingness to participate.Conclusion Healthy volunteers are motivated by both altruistic and self-interest factors besides compensation,such as obtaining free healthcare,social interaction,contributing to medical research,and helping others with medication.Factors affecting trial motivation include trial risks,participant age,gender,marital status,trial experience,privacy,and the competence and ward management level of researchers.
维普
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