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（由申请人提供）：拟建项目将调查健康志愿者参与I期临床试验的模式，根据以下差异进行处理