Abstract
BackgroundIncreasing 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.ObjectiveThis study’s purpose is to describe sociodemographic characteristics and clinical trial participation histories of healthy people who enroll in US Phase I trials.MethodsThe 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.ResultsThe 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.ImplicationsParticipation 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.
Highlights
People from disadvantaged sociodemographic groups, especially people of color, are more likely to participate as healthy volunteers in US Phase I clinical trials that test drug toxicity levels and side effects [1,2,3]
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
We present data collected during the HealthyVOICES Project (HVP), a longitudinal, mixed-methods study of healthy individuals who participated in at least one Phase I clinical trial
Summary
People from disadvantaged sociodemographic groups, especially people of color, are more likely to participate as healthy volunteers in US Phase I clinical trials that test drug toxicity levels and side effects [1,2,3]. Unlike the improvements that have been made in later-phase trials, women continue to be underrepresented as healthy volunteers in Phase I trials [6]. This misaligned representation in clinical trial research is troubling for reasons of equity and justice that warrant further examination [7,8,9]. Research has found that healthy volunteers are often not one-time participants but are “serial” participants who are likely to enroll repeatedly in Phase I trials [10,11,12]. Healthy volunteers can derive no medical benefit from their participation, and they are financially compensated for enrolling
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