Post-Trial Access for Insured and Uninsured Participants

投保和未投保参与者的试验后访问

基本信息

  • 批准号:
    7272821
  • 负责人:
  • 金额:
    $ 46.72万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2005
  • 资助国家:
    美国
  • 起止时间:
    2005-09-29 至 2008-06-30
  • 项目状态:
    已结题

项目摘要

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):最近人们对临床试验中试验后获得研究干预措施的机会提出了担忧,特别是对于没有保险的弱势群体。这些和其他影响弱势群体参与人类受试者研究的问题引发了研究风险、负担和收益的公平分配问题。然而,关于预测试验后访问的因素以及研究志愿者的组成、动机和经验的实证数据却很少。我们提出的研究旨在:1)描述临床试验参与者在试验后获得护理的情况,包括获得所研究的干预措施或同等治疗的情况,并评估保险状况是否是一个独立的预测因素; 2) 测试保险状况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、不良事件的处理以及作为获得护理的手段参与多项试验。为了实现这些目标,我们将在 3 个时间点对参加 IIIB 和 IV 期后期临床试验的全国志愿者样本进行调查:入组时;退出试验后以及试验结束后大约 6 个月。拟议的研究旨在收集人类受试者在临床研究中的经验的经验数据,这些数据可能反映研究企业的道德方面(但不是评估任何特定试验的道德行为),并提供有助于评估研究风险和负担的公正分配的经验信息。

项目成果

期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Subjects' views of obligations to ensure post-trial access to drugs, care and information: qualitative results from the Experiences of Participants in Clinical Trials (EPIC) study.
受试者对确保对药物的审判访问,护理和信息的义务的看法:来自临床试验参与者的经验(EPIC)研究的定性结果。
  • DOI:
    10.1136/jme.2008.024711
  • 发表时间:
    2009-03
  • 期刊:
  • 影响因子:
    4.1
  • 作者:
    Sofaer N;Thiessen C;Goold SD;Ballou J;Getz KA;Koski G;Krueger RA;Weissman JS
  • 通讯作者:
    Weissman JS
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Joel S. Weissman其他文献

MP32-08 ACCOUNTABLE CARE ORGANIZATIONS AND THE USE OF PROSTATE CANCER SCREENING
  • DOI:
    10.1016/j.juro.2017.02.983
  • 发表时间:
    2017-04-01
  • 期刊:
  • 影响因子:
  • 作者:
    Christian P. Meyer;Anna Krasnova;Jesse D. Sammon;Philipp Gild;Nicolas von Landenberg;Stuart R. Lipsitz;Joel S. Weissman;Felix K.H. Chun;Margit Fisch;Maxine Sun;Quoc-Dien Trinh
  • 通讯作者:
    Quoc-Dien Trinh
Understanding the Roles, Responsibilities, and Factors for Success of Health Equity Officers in Health Care Settings: A Qualitative Study
了解卫生保健机构中健康公平官员的角色、责任和成功因素:定性研究
Patients with dementia or frailty undergoing major limb amputation have poor outcomes
患有痴呆症或身体虚弱的患者接受大肢体截肢后预后较差。
  • DOI:
    10.1016/j.jvs.2024.08.058
  • 发表时间:
    2025-01-01
  • 期刊:
  • 影响因子:
    3.600
  • 作者:
    Samir K. Shah;Lingwei Xiang;Rachel R. Adler;Clancy J. Clark;John Hsu;Susan L. Mitchell;Emily Finlayson;Dae Hyun Kim;Kueiyu Joshua Lin;Joel S. Weissman
  • 通讯作者:
    Joel S. Weissman
The impact of patient socioeconomic status and other social factors on readmission: a prospective study in four Massachusetts hospitals.
患者社会经济状况和其他社会因素对再入院的影响:在马萨诸塞州四家医院进行的一项前瞻性研究。
Should obtaining a preoperative audiogram before tympanostomy tube placement be used as a quality metric? A survey of pediatric otolaryngologists
  • DOI:
    10.1016/j.ijporl.2016.06.004
  • 发表时间:
    2016-09-01
  • 期刊:
  • 影响因子:
  • 作者:
    Nikhila Raol;Christopher J. Hartnick;Joel S. Weissman
  • 通讯作者:
    Joel S. Weissman

Joel S. Weissman的其他文献

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{{ truncateString('Joel S. Weissman', 18)}}的其他基金

Understanding and Improving Surgical Decision-Making for Persons Living with Dementia, their Family Caregivers, and their Providers: A Mixed Methods Study
了解和改善痴呆症患者、其家庭护理人员及其提供者的手术决策:一项混合方法研究
  • 批准号:
    10405060
  • 财政年份:
    2020
  • 资助金额:
    $ 46.72万
  • 项目类别:
Understanding and Improving Surgical Decision-Making for Persons Living with Dementia, their Family Caregivers, and their Providers: A Mixed Methods Study
了解和改善痴呆症患者、其家庭护理人员及其提供者的手术决策:一项混合方法研究
  • 批准号:
    9973606
  • 财政年份:
    2020
  • 资助金额:
    $ 46.72万
  • 项目类别:
Understanding and Improving Surgical Decision-Making for Persons Living with Dementia, their Family Caregivers, and their Providers: A Mixed Methods Study
了解和改善痴呆症患者、其家庭护理人员及其提供者的手术决策:一项混合方法研究
  • 批准号:
    10848596
  • 财政年份:
    2020
  • 资助金额:
    $ 46.72万
  • 项目类别:
Understanding and Improving Surgical Decision-Making for Persons Living with Dementia, their Family Caregivers, and their Providers: A Mixed Methods Study
了解和改善痴呆症患者、其家庭护理人员及其提供者的手术决策:一项混合方法研究
  • 批准号:
    10595437
  • 财政年份:
    2020
  • 资助金额:
    $ 46.72万
  • 项目类别:
Understanding and Improving Surgical Decision-Making for Persons Living with Dementia, their Family Caregivers, and their Providers: A Mixed Methods Study
了解和改善痴呆症患者、其家庭护理人员及其提供者的手术决策:一项混合方法研究
  • 批准号:
    10617273
  • 财政年份:
    2020
  • 资助金额:
    $ 46.72万
  • 项目类别:
Understanding and Improving Surgical Decision-Making for Persons Living with Dementia, their Family Caregivers, and their Providers: A Mixed Methods Study
了解和改善痴呆症患者、其家庭护理人员及其提供者的手术决策:一项混合方法研究
  • 批准号:
    10589248
  • 财政年份:
    2020
  • 资助金额:
    $ 46.72万
  • 项目类别:
Identifying barriers, facilitators and outcomes of Advanced Care Planning conversations with Medicare patients
确定与 Medicare 患者进行高级护理计划对话的障碍、促进因素和结果
  • 批准号:
    9763016
  • 财政年份:
    2017
  • 资助金额:
    $ 46.72万
  • 项目类别:
Advance Care Planning (ACP) among Sexual and Gender Minority Individuals and Their Caregivers
性少数群体及其护理人员的预先护理计划 (ACP)
  • 批准号:
    10093464
  • 财政年份:
    2017
  • 资助金额:
    $ 46.72万
  • 项目类别:
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
  • 财政年份:
    2005
  • 资助金额:
    $ 46.72万
  • 项目类别:
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:
    7034003
  • 财政年份:
    2005
  • 资助金额:
    $ 46.72万
  • 项目类别:

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