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

影响健康志愿者长期参与临床试验的因素

基本信息

批准号：
8611663
负责人：
JILL A FISHER
金额：
$ 3.85万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-05 至 2017-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8611663
关键词：
Address Affect African American Alcohols Behavior Benefits and Risks Blood Clinical Trials Consent Forms Control Groups Decision Making Development Enrollment Ethics Ethnic group Exclusion Criteria Financial compensation Health Health Benefit Hispanics Illicit Drugs Incentives Individual Interview Investigation Investigational Drugs Knowledge Lead Length Light Logistics Longitudinal Studies Medical Research Minority Minority Groups Not Hispanic or Latino Participant Pattern Perception Pharmaceutical Preparations Phase Phase I Clinical Trials Phase III Clinical Trials Population Procedures Psychotropic Drugs Public Health Qualifying Race Recommendation Recruitment Activity Research Research Design Research Personnel Risk Structure Therapeutic Clinical Trial Time Tobacco United States National Institutes of Health Weight base design diaries healthy volunteer improved insight member phase 1 study prospective racial and ethnic risk perception safety testing self reported behavior tool volunteer

项目摘要

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 overtime; 2. Examine how participants make decisions regarding their participation in clinical trials - including continuing serial participation - 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 harm 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 participate 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 Phase 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.

拟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，关注基于其种族和民族背景的差异。它重点关注健康志愿者对参与试验的风险和益处的看法与他们围绕这些研究的入组决策和行为之间随时间的关系。临床试验中的大多数健康志愿者都是连续参与者，这意味着他们重复参加研究，因此需要纵向研究设计来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收益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有关参与临床试验的决定（包括持续连续参与），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（a）如何影响临床试验的有效性和（b）增加和/或减轻连续参与可能带来的伤害，包括对健康有益的行为；和 4. 比较不同种族和族裔群体的参与者的看法、决定和行为。这个为期 5 年的项目是一项前瞻性、纵向、定性研究，包括 200 名健康志愿者（50 名第一次第一阶段参与者、50 名第二次参与者、50 名第三至第五次参与者和 50 名第六次以上参与者），他们将跟踪3年。他们将参加 5 次半结构化面试（总共 880 次）：入学时、6 个月、1 年、2 年和 3 年。参与者还将保留“临床试验日记”，记录他们在访谈之间的第一阶段研究活动。每组 10 名参与者将作为对照组，仅在入学时和三年后接受采访。对照组将用于评估访谈和日记在研究过程中是否对志愿者产生意外的干预作用。