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

• 批准号: 8536871
• 负责人: JILL A FISHER
• 金额: $ 35.72万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 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/8536871
• 关键词: Address; Affect; African American; Alcohols; Behavior; Benefits and Risks; Blood; Clinical; 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; Vent; 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

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.

描述（申请人提供）：拟开展的项目将调查健康志愿者参与I期临床试验的模式，并根据以下因素关注差异： 他们的种族背景它侧重于健康志愿者对参与试验的风险和益处的看法与他们在这些研究中的决策和行为之间的关系。临床试验中的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益处的看法如何随时间变化; 2.检查参与者如何决定他们是否参与临床试验-包括继续参加系列试验-并评估他们的选择随着时间的推移的一致性; 3.记录参与者自我报告的行为如何（a）影响临床试验的有效性和（B）增加和/或减轻可能来自连续参与的har，包括具有健康益处的行为;以及4.比较不同种族和民族的参与者的看法、决定和行为。这项为期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1次I期参与者、50名第2次参与者、50名第3 - 5次参与者和50名第6次以上参与者），他们将接受3年的随访。他们将参加5次半结构化面试（总共880人）：入学时、6个月、1年、2年和3年。受试者还将保留“临床试验日记”，记录他们在两次访谈之间的Phae I研究活动。在每组中，10名参与者将作为对照，仅在入组时和三年后接受采访。对照组将用于评价访谈和日记在研究过程中是否对志愿者产生非预期的干预作用。