Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
Clinical Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
Eur J Clin Pharmacol. 2022 Oct;78(10):1647-1655. doi: 10.1007/s00228-022-03366-3. Epub 2022 Jul 27.
Clinical research relies on data from patients and volunteers, yet the target sample size is often not achieved. Here, we assessed the perception of clinical research among clinical trial participants to improve the recruitment process for future studies.
We conducted a single-center descriptive and exploratory study of 300 current or former participants in various phase I-III clinical trials. Questionnaires were either distributed to current clinical trial participants or emailed to former subjects.
Subjects strongly agreed or agreed that contributing to improving medical care (> 81%), contributing to scientific research (> 79%), and trusting their treating physicians (> 77%) were motives for study participation. Among healthy volunteers, financial motives positively correlated with the number of clinical trials they had participated in (p < 0.05). Higher age positively correlated with expectation of best available treatment during study participation among patients (p < 0.05). Less than 8% of all subjects expressed "great concern" about the potential risks of sharing their personal information as part of the study. Subjects displayed "great trust" or "trust" in medical staff (86.6%) and in government research institutions (76.4%), and "very little trust" or "little trust" in pharmaceutical companies (35.4%) and health insurance companies (16.9%).
Altruistic motives and trust in treating physicians were predominant motives for clinical trial participation. Older patients expected to receive the best available treatment during participation. Healthy volunteers who reported financial motives had participated in more clinical trials. Consistent with great trust in medical staff and government research institutions, little concern was expressed about the misuse of personal data during the trial.
临床研究依赖于患者和志愿者提供的数据，但通常无法达到目标样本量。在这里，我们评估了临床试验参与者对临床研究的看法，以改进未来研究的招募流程。
我们对 300 名正在参加或曾经参加过各种 I-III 期临床试验的参与者进行了一项单中心描述性和探索性研究。问卷要么分发给当前的临床试验参与者，要么通过电子邮件发送给以前的研究对象。
受试者强烈同意或同意参与研究的动机是改善医疗保健（>81%）、促进科学研究（>79%）和信任他们的治疗医生（>77%）。在健康志愿者中，经济动机与他们参加的临床试验数量呈正相关（p<0.05）。年龄越高，患者在研究期间对接受最佳可用治疗的期望越高（p<0.05）。不到 8%的受试者对在研究中分享个人信息的潜在风险表示“非常关注”。受试者对医务人员（86.6%）和政府研究机构（76.4%）表现出“极大的信任”或“信任”，对制药公司（35.4%）和医疗保险公司（16.9%）表现出“很少信任”或“不信任”。
利他主义动机和对治疗医生的信任是参与临床试验的主要动机。年龄较大的患者期望在参与期间接受最佳可用的治疗。报告有经济动机的健康志愿者参加了更多的临床试验。与对医务人员和政府研究机构的极大信任一致，对试验期间个人数据滥用的担忧很少。
