Post-Trial Access for Insured and Uninsured Participants

投保和未投保参与者的试验后访问

• 批准号: 7127726
• 负责人: Joel S. Weissman
• 金额: $ 53.37万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-29 至 2008-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7127726
• 关键词: clinical research; clinical trials; ethics; health care service availability; health insurance; health science research analysis /evaluation; health services research tag; human subject; longitudinal human study; patient oriented research; population survey

DESCRIPTION (provided by applicant): Concerns have been raised recently about post-trial access to studied interventions in clinical trials, especially for vulnerable populations like the uninsured. These and other issues affecting the participation of vulnerable populations in human subjects research raise issues of the fair distribution of the risks, burdens and benefits of research. Yet little empirical data exists about factors that predict post-trial access, nor about the composition, motivation and experience of research volunteers. Our proposed study seeks to: 1) Describe post-trial access to care among participants in clinical trials, including access to the studied intervention or a therapeutic equivalent, and to assess whether insurance status is an independent predictor; and 2) Test associations between insurance status and selected aspects of the clinical trial experience, including reasons for enrollment/disenrollment, handling of adverse events, and participation in multiple trials as a means of obtaining access to care. To accomplish these aims, we will survey a national sample of volunteers in late phase clinical trials of type phase IIIB and IV at 3 points in time: upon enrollment; upon exit from the trial, and approximately 6 months after the trial ends. The proposed research is intended to gather empirical data on the experience of human subjects in clinical research that may reflect ethical aspects of the research enterprise (but not to assess ethical conduct of any particular trial), and to provide empirical information that will help to evaluate the just distribution of the risks and burdens of research.

描述（由申请人提供）：最近已经提出了有关在临床试验中进行研究干预措施的审判后访问的担忧，尤其是对于像未投保的弱势群体。这些和其他影响脆弱人群参与人类受试者的问题的问题提出了有关研究风险，负担和研究益处的公平分布的问题。然而，关于预测后审判访问的因素，也没有关于研究志愿者的组成，动机和经验几乎没有经验数据。我们拟议的研究试图：1）描述参与者在临床试验中参与者的监护后访问，包括接受研究的干预措施或治疗等效物，并评估保险状况是否是独立的预测因素； 2）保险状态与临床试验经验的选定方面之间的测试关联，包括入学/分散的原因，处理不良事件以及参与多次试验的原因，以获取获得护理的手段。为了实现这些目标，我们将在3阶段的后期临床试验中调查全国志愿者在3个时间点进行的临床试验：入学时；退出试验后，审判结束后约6个月。拟议的研究旨在收集有关人类受试者在临床研究中的经验的经验数据，这些数据可能反映了研究企业的道德方面（但不能评估任何特定试验的道德行为），并提供经验信息，以帮助评估研究风险和研究的风险分布。