Center for Infectious Diseases, Leiden University, Leiden University Medical Center, Albinusdreef 2, 2333ZA, Leiden, The Netherlands.
Medical Ethics and Health Law, Leiden University Medical Center, Albinusdreef 2, Leiden, 2333ZA, The Netherlands.
Trials. 2024 Nov 6;25(1):740. doi: 10.1186/s13063-024-08582-z.
Scientific advancement, including the testing and licensing of new drugs, relies heavily on clinical trials with healthy individuals. The motivations of clinical trial participants have been discussed intensively, as some worry that financial compensation may distract from the intrinsic risk of clinical research. Herein, we investigated the motivations and decisional factors influencing SARS-CoV-2 clinical trial participants. Moreover, since most surveys are administered after clinical trial participation, we were interested in whether the results were tainted by recall bias.
This was a cross-sectional observational study. Participants were administered a survey on two occasions, once before and once after participation in a clinical trial. The primary outcomes were the motivations and decisional factors of SARS-CoV-2 vaccine trial participants and the difference between the surveys collected before and after clinical trial participation.
The survey response rate was 149/200 (75%). SARS-CoV-2 vaccine trial participants were mostly motivated by the desire to contribute to science and help others. Answers collected before and after the trial were not statistically different, indicating the absence of recall bias.
The decision-making process of clinical trial participants is complex and multi-faceted. Previous studies have shown that clinical trial participants have mixed motivations but never to the extent reported in the current survey. Here, we present a theoretical framework that attempts to explain how different motivational factors may contribute to decision forming.
科学进步，包括新药的测试和许可，严重依赖于健康个体的临床试验。临床试验参与者的动机已经被广泛讨论，因为一些人担心经济补偿可能会分散对临床研究内在风险的关注。在此，我们研究了 SARS-CoV-2 临床试验参与者的动机和决策因素。此外，由于大多数调查都是在临床试验参与之后进行的，我们有兴趣了解结果是否受到回忆偏差的影响。
这是一项横断面观察性研究。参与者在两次不同的时间接受了调查，一次是在参与临床试验之前，一次是在之后。主要结局是 SARS-CoV-2 疫苗试验参与者的动机和决策因素，以及临床试验前后两次调查的差异。
调查的回复率为 149/200（75%）。SARS-CoV-2 疫苗试验参与者主要是出于为科学做出贡献和帮助他人的愿望。在试验前后收集的答案没有统计学差异，表明没有回忆偏差。
临床试验参与者的决策过程是复杂的、多方面的。先前的研究表明，临床试验参与者的动机是混合的，但从未达到目前调查中报告的程度。在这里，我们提出了一个理论框架，试图解释不同的动机因素如何有助于决策形成。
