Factors Affecting Healthy Volunteers' Long-Term Participation in Clinical Trials

描述(由申请者提供)：建议的项目将调查健康志愿者参与第一阶段临床试验的模式，关注基于以下方面的差异 他们的种族和民族背景。它关注的是随着时间的推移，健康志愿者对参与试验的风险和好处的感知与他们在这些研究中的决策和行为之间的关系。在临床试验中，大多数健康志愿者是连续参与者，这意味着他们重复参加研究，因此需要进行纵向研究设计，以了解他们参与临床试验的模式。该项目的设计有四个主要目标：1.评估参与者对第一阶段参与的风险和好处的看法如何随着时间的推移而变化；2.检查参与者如何做出关于他们参与临床试验的决定--包括持续的连续参与--并评估他们的选择随着时间的推移的一致性；3.记录参与者的自我报告行为如何(A)影响临床试验的有效性，以及(B)增加和/或减轻可能来自连续参与的危害，包括对健康有益的行为；4.比较不同种族和民族的参与者的感知、决定和行为。这个为期5年的项目是一项前瞻性、纵向、定性的研究，包括200名健康志愿者(50名第一阶段参与者，50名第二次参与者，50名第三至第五次参与者，50名第六次以上参与者)，他们将被跟踪3年。他们将参加5次半结构化面试(共880次)：注册时、6个月、1年、2年和3年。参与者还将保存“临床试验日记”，记录他们在两次访谈之间的第一阶段研究中的活动。在每组中，10名参与者将作为对照，仅在注册时和三年后接受采访。对照组将被用来评估在研究过程中，采访和日记是否对志愿者产生了意想不到的干预效果。

DESCRIPTION (provided by applicant): The proposed project will investigate healthy volunteers' patterns of participation in Phase I clinical trials, attending to differences based on their racial and ethnic backgrounds. It focuses on the relationship over time between healthy volunteers' perceptions of the risks and benefits of trial participation and their decision-making and behaviors surrounding enrollment in those studies. The majority of healthy volunteers in clinical trials are serial participants, meaning that they enroll repeatedly in studies, so a longitudinal study design is needed to understand their patterns of participation in clinical trial. The project is designed with four primary aims: 1. Assess how participants' perceptions of the risks and benefits of Phase I participation change over time; 2. Examine how participants make decisions regarding their participation in clinical trials - including continuing serial participaion - and assess the consistency of their choices over time; 3. Document how participants' self-reported behaviors (a) affect the validity of clinical trials and (b) increase and/or mitigate har that could come from serial participation, including behaviors that have health benefits; and 4. Compare participants' perceptions, decisions, and behaviors across racial and ethnic groups. This 5-year project is a prospective, longitudinal, qualitative study and includes 200 healthy volunteers (50 1st-times Phase I participants, 50 2nd-time participants, 50 3rd-5th-time participants, and 50 6th+-time participants) who will be followed for 3 years. They will participat in 5 semi-structured interviews (total of 880): at enrollment, 6 months, 1 year, 2 years, and 3 years. Participants will also maintain "clinical trial diaries" documenting their activities in Phae I studies between interviews. In each group, 10 participants will serve as controls and be interviewed only at enrollment and at three years. The control group will be used to evaluate whether the interviews and diaries have an unintended interventional effect on volunteers over the course of the study.