Department of Public Health Sciences, Clemson University, Clemson, SC, United States of America.
Department of Bioengineering, Clemson University, Clemson, SC, United States of America.
PLoS One. 2021 Sep 7;16(9):e0256994. doi: 10.1371/journal.pone.0256994. eCollection 2021.
BACKGROUND: Increasing the diversity of research participants is an important focus of clinical trials. However, little is known regarding who enrolls as healthy volunteers in Phase I clinical trials, which test the safety and tolerability of investigational new drugs. Despite the risk, healthy volunteers can derive no medical benefit from their participation, and they are financially compensated for enrolling. OBJECTIVE: This study's purpose is to describe sociodemographic characteristics and clinical trial participation histories of healthy people who enroll in US Phase I trials. METHODS: The HealthyVOICES Project (HVP) is a longitudinal study of healthy individuals who have enrolled in Phase I trials. We describe self-reported sociodemographic information and Phase I trial history from HVP recruitment (May-December 2013) through the project's end three years later (December 2016). Trial experiences are presented as medians and quartiles. RESULTS: The HVP included 178 participants. Nearly three-fourths of participants were male, and two-thirds were classified as racial and ethnic minorities. We found that some groups of participants were more likely to have completed a greater number of clinical trials over a longer timeframe than others. Those groups included participants who were male, Black, Hispanic, 30-39-years-old, unemployed, had received vocational training in a trade, or had annual household incomes of less than $25,000. Additionally, the greater the number of clinical trials participants had completed, the more likely they were to continue screening for new trials over the course of three years. Participants who pursued clinical trials as a full-time job participated in the greatest number of trials and were the most likely to continuing screening over time. IMPLICATIONS: Participation as a healthy volunteer in US Phase I trials is driven by social inequalities. Disadvantaged groups tend to participate in a greater number of clinical trials and participate longer than more privileged groups.
背景:增加研究参与者的多样性是临床试验的一个重要关注点。然而,人们对谁作为健康志愿者参加 I 期临床试验(测试新的研究性药物的安全性和耐受性)知之甚少。尽管有风险,但健康志愿者从参与中无法获得任何医疗益处,并且他们因参与而获得经济补偿。
目的:本研究旨在描述在美国 I 期试验中招募的健康志愿者的社会人口统计学特征和临床试验参与史。
方法:健康志愿者声音项目(HVP)是一项对参加过 I 期试验的健康个体的纵向研究。我们描述了 HVP 招募(2013 年 5 月至 12 月)至项目结束三年后的 HVP 参与者的自我报告社会人口统计学信息和 I 期试验史(2016 年 12 月)。试验经验以中位数和四分位数表示。
结果:HVP 包括 178 名参与者。近四分之三的参与者为男性,三分之二的参与者被归类为种族和少数民族。我们发现,一些群体的参与者比其他群体更有可能在更长的时间内完成更多的临床试验。这些群体包括男性、黑人、西班牙裔、30-39 岁、失业、接受过职业培训或年收入低于 25,000 美元的参与者。此外,参与者完成的临床试验数量越多,他们在三年内继续筛选新试验的可能性就越大。将临床试验作为全职工作的参与者参加了最多的试验,并且随着时间的推移继续筛选的可能性最高。
意义:作为美国 I 期临床试验的健康志愿者参与受到社会不平等的驱动。弱势群体比较有优势的群体更有可能参加更多的临床试验,并且参与时间更长。
Cochrane Database Syst Rev. 2022-2-1
Am J Public Health. 2011-10-20
J Empir Res Hum Res Ethics. 2018-12
J Acquir Immune Defic Syndr. 2009-6-1
Front Pharmacol. 2025-8-1
BMC Med Ethics. 2025-4-24
J Empir Res Hum Res Ethics. 2025
Clin Pharmacol Drug Dev. 2025-1
J Racial Ethn Health Disparities. 2024-10
Cochrane Database Syst Rev. 2023-9-1
Scand J Work Environ Health. 2021-4-1
J Empir Res Hum Res Ethics. 2018-12