Healthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time.

<h4>Background</h4>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...

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Autores principales:	Corey A Kalbaugh, Julianne M Kalbaugh, Lisa McManus, Jill A Fisher
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/6c0931c9a3ed437cb017785e2c069a62
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spelling	oai:doaj.org-article:6c0931c9a3ed437cb017785e2c069a622021-12-02T20:08:30ZHealthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time.1932-620310.1371/journal.pone.0256994https://doaj.org/article/6c0931c9a3ed437cb017785e2c069a622021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0256994https://doaj.org/toc/1932-6203<h4>Background</h4>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.<h4>Objective</h4>This study's purpose is to describe sociodemographic characteristics and clinical trial participation histories of healthy people who enroll in US Phase I trials.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Implications</h4>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.Corey A KalbaughJulianne M KalbaughLisa McManusJill A FisherPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 9, p e0256994 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Corey A Kalbaugh Julianne M Kalbaugh Lisa McManus Jill A Fisher Healthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time.
description	<h4>Background</h4>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.<h4>Objective</h4>This study's purpose is to describe sociodemographic characteristics and clinical trial participation histories of healthy people who enroll in US Phase I trials.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Implications</h4>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.
format	article
author	Corey A Kalbaugh Julianne M Kalbaugh Lisa McManus Jill A Fisher
author_facet	Corey A Kalbaugh Julianne M Kalbaugh Lisa McManus Jill A Fisher
author_sort	Corey A Kalbaugh
title	Healthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time.
title_short	Healthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time.
title_full	Healthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time.
title_fullStr	Healthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time.
title_full_unstemmed	Healthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time.
title_sort	healthy volunteers in us phase i clinical trials: sociodemographic characteristics and participation over time.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/6c0931c9a3ed437cb017785e2c069a62
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Healthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time.

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