Post-Trial Access for Insured and Uninsured Participants

描述（由申请人提供）：最近人们对临床试验中研究干预措施的试验后访问提出了担忧，特别是对于未投保的弱势人群。这些问题和其他影响弱势群体参与人体研究的问题提出了公平分配研究风险、负担和利益的问题。然而，很少有经验数据存在的因素，预测试验后访问，也没有关于研究志愿者的组成，动机和经验。我们建议的研究旨在：1）描述临床试验参与者在试验后获得护理的情况，包括获得研究的干预措施或治疗等效物的情况，并评估保险状况是否是一个独立的预测因素;和2）检验保险状态与临床试验经验的选定方面之间的关联，包括入组/退出的原因，不良事件的处理，并参与多项试验，作为获得护理的一种手段。为了实现这些目标，我们将在3个时间点对IIIB期和IV期临床试验晚期的全国志愿者样本进行调查：入组时;退出试验时，以及试验结束后约6个月。拟议的研究旨在收集临床研究中人类受试者经验的经验数据，这些数据可能反映研究企业的伦理方面（但不是评估任何特定试验的伦理行为），并提供经验信息，有助于评估研究风险和负担的公平分配。

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.