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: 8370327
• 负责人: JILL A FISHER
• 金额: $ 37.62万
• 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/8370327
• 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. PUBLIC HEALTH RELEVANCE: It is critical to understand the patterns of healthy volunteers' participation in Phase I clinical trials, including differences in the participation of minority grups in these early-phase studies. Through this knowledge, efforts can be made to better protect the health of participants as well as to improve their understanding of the risks of serial participatin in clinical trials. In addition, this project can help identify factors associated with serial participation that could affect the validity of clinical trials and potentially threaten the publics health.

描述（由申请人提供）：拟议项目将调查健康志愿者参与 I 期临床试验的模式，并根据不同情况关注差异 他们的种族和民族背景。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产生的伤害，包括对健康有益的行为； 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”，记录他们在访谈期间在 Phae I 研究中的活动。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。 公共卫生相关性：了解健康志愿者参与 I 期临床试验的模式至关重要，包括少数群体参与这些早期研究的差异。通过这些知识，可以更好地保护参与者的健康，并提高他们对连续参与临床试验的风险的了解。此外，该项目可以帮助确定与连续参与相关的因素，这些因素可能会影响临床试验的有效性并可能威胁公众健康。