HealthyVOICES data for article about the sociodemographic characteristics and participation over time of healthy volunteers in Phase I clinical trials

This is the dataset that was used for a manuscript about the sociodemographic characteristics and participation over time of healthy volunteers in US phase I clinical trials.

The abstract of that paper is as follows:
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.

本数据集用于一篇探讨美国I期临床试验（Phase I clinical trials）健康志愿者的社会人口学特征与长期参与情况的学术论文。

该论文的摘要如下：
研究背景 提高研究受试者的多样性是临床试验的重要关注点。然而，针对I期临床试验——其核心为评估研究性新药的安全性与耐受性——中健康志愿者招募对象的相关研究仍较为匮乏。尽管参与试验存在风险，但健康志愿者无法从参与中获得任何医疗收益，仅能获得参与试验的经济补偿。
研究目的 本研究旨在描述参与美国I期临床试验的健康人群的社会人口学特征与临床试验参与史。
研究方法 HealthyVOICES项目（HealthyVOICES Project, HVP）是一项针对参与过I期临床试验的健康个体的纵向研究。本研究梳理了该项目自2013年5月至12月招募阶段，至2016年12月项目结束（历时三年）期间收集的自我报告式社会人口学信息与I期临床试验参与史。试验相关经历以中位数及四分位数进行呈现。
研究结果 HVP共纳入178名受试者。近四分之三的受试者为男性，三分之二的受试者属于种族与少数民族群体。研究发现，部分受试者群体相较于其他群体，更有可能在更长时间内完成更多数量的临床试验：这类群体包括男性、黑人、西班牙裔、30至39岁人群、失业人员、接受过行业职业培训者，或家庭年收入低于25000美元的人群。此外，受试者既往完成的临床试验数量越多，在三年研究期间持续筛查新试验的可能性就越高。以临床试验参与作为全职工作的受试者，参与的试验数量最多，且在研究期间持续参与筛查的概率也最高。
研究启示 美国I期临床试验中健康志愿者的参与行为受社会不平等因素驱动。相较于优势群体，弱势群体往往参与更多数量的临床试验，且参与时长更长。