Research and Treatment in Comparative Effectiveness, QI and IND Research

比较有效性、QI 和 IND 研究的研究和治疗

• 批准号: 7822049
• 负责人: RUTH R FADEN
• 金额: $ 48.94万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-25 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7822049
• 关键词: Affect; American; Area; Attention; Bioethics; Caring; Case Study; Clinical; Clinical Research; Clinical Trials; Communicable Diseases; Conduct Clinical Trials; Controlled Environment; Data Collection; Development; Devices; Diabetes Mellitus; Drug Interactions; Elements; Eligibility Determination; Empirical Research; Enrollment; Ensure; Environment; Ethics; Funding; Future; Health Services; Health system; Healthcare; Heart Diseases; Human; Individual; Informed Consent; Infusion procedures; Intervention; Investigation; Knowledge; Label; Learning; Malignant Neoplasms; Medical; Medical Research; Moral Policies; Morals; Nature; Outcome; Participant; Patient Care; Patients; Pharmaceutical Preparations; Physicians; Policies; Policy Analysis; Public Policy; Publishing; Randomized; Reaction; Recommendation; Recording of previous events; Regulation; Research; Research Ethics; Research Ethics Committees; Research Methodology; Research Personnel; Scholarship; Terminology; Testing; Textbooks; Therapeutic; Therapeutic Human Experimentation; Therapeutic Studies; Thinking; Time; United States; Upper arm; Woman; Work; base; catalyst; comparative effectiveness; design; dosage; effectiveness research; experience; flexibility; human subject; interest; malignant breast neoplasm; meetings; nervous system disorder; outer surface lipoprotein; payment; phrases; programs; response; sound; systems research; therapeutic misconception; working group

DESCRIPTION (provided by applicant): Research Area: Challenge Area: Bioethics Challenge Topic: 02-OD (OSP)-105* More than two million Americans with cancer, heart disease, infectious diseases, diabetes, neurological disorders and other conditions are enrolled in clinical research in the United States each year. For many of these patient-subjects, participation is viewed, by them and by their physicians, as a means of treating or responding to their medical condition. Moreover, the infusion of billions of dollars into comparative effectiveness research and quality improvement research over the coming years ensures that soon many more patients will be receiving care that, in one way or another, is integrated with clinical and health services systems research. Indeed, there is growing recognition that high value health care will be achievable only if the outcomes of medical interventions and practices are continuously under study. As such, research methods and funding are rapidly changing to respond to this practical need. . The challenge with this shifting environment is to adapt traditional paradigms for the ethics of research to this new paradigm for a research and treatment interface, where research and treatment are increasingly, yet to varying degrees, integrated in what some have called the total learning environment. This project is intended to begin to fill the knowledge and policy gap in research ethics created by the increasing integration of research with treatment. Useful policy guidance is critically needed that is responsive to the integrated nature of research and treatment across research approaches, including the three research areas on which this project will focus: " Traditional clinical trials of unapproved drugs/devices; " Comparative Effectiveness research; " Quality Improvement research. Without such guidance, much needed research may be inappropriately impeded by oversight norms ill suited to this evolving context. Thus, we expect this work to be a significant down payment on much needed rethinking of the how best to craft human research protections for the broadening federal research program and the health system of the future in which research and treatment are increasingly intertwined. This project will accomplish its work through ongoing, collaborative meetings of a core group of six experts in research ethics, clinical trials, comparative effectiveness, quality improvement, and/or public policy. Through sub-group and core group interactions, the development of rich case studies, and empirical data collection, this project will produce a conceptual analysis that considers a research-treatment interface rather than exclusively a separation, and will produce policy guidance and safeguards relevant to our evolving research agenda. The aims of this project include: Aim 1: Produce a clear, conceptual analysis that defines and characterizes the constitutive elements of "research" and "treatment" through the development of rich case studies of specific examples of (a) clinical trials of unapproved drugs and devices (CTUn); (b) comparative effectiveness (CE) research; and (c) quality improvement (QI) research, against which the conceptual analysis can be tested and refined; Aim 2: Examine the implications of this conceptual analysis for the moral and policy purposes to which the research-treatment distinction has been and continues to be put, with particular focus on rich case studies developed from CTUn, CE, and QI research; Aim 3: Conduct empirical research with investigators who conduct CTUn, CE, and QI research to (a) list a range of designs and examples within their area and discuss how constitutive elements of research and treatment apply; and (b) later, with additional inclusion of federal officials, to elicit reactions to draft conceptual and moral analyses and policy recommendations for feasibility and applicability; Aim 4: Based on our conceptual, moral, and empirical findings, develop policy guidance and safeguards for research participants in CTUn, CE, and QI research specific to investigators, to informed consent, and to research oversight. This project examines the research-treatment interface in the context of traditional clinical trials, comparative effectiveness research, and quality improvement research. Through the regular interaction of a small, collaborative expert working group, development of rich case studies, and empirical data collection, we will draft an original conceptual framework for the research-treatment interface as well as policy recommendations for research oversight and informed consent.

描述（由申请人提供）： 研究领域：挑战领域：生物伦理学挑战主题：02-OD（OSP）-105*每年有超过200万美国人患有癌症，心脏病，传染病，糖尿病，神经系统疾病和其他疾病的美国人。对于许多患者受试者，他们及其医生都认为参与是治疗或应对其医疗状况的一种手段。此外，在接下来的几年中，将数十亿美元注入比较有效性研究和质量改进研究中，可确保不久将有更多患者接受护理，以一种或另一种方式将其与临床和卫生服务系统研究融为一体。确实，只有在不断研究医疗干预和实践的结果时，才越来越认识到，高价值的医疗保健才能实现。因此，研究方法和资金正在迅速改变，以应对这种实际需求。 。这种不断变化的环境面临的挑战是将传统的研究范式适应研究和治疗界面的新范式，在这种新范式上，研究和治疗越来越多，但在不同程度上却既包含在某些人称为总学习环境中。该项目旨在开始填补研究伦理学的知识和政策差距，而研究伦理学的研究伦理学越来越多地融合了研究。有用的政策指导是至关重要的，这对研究和研究方法的综合性质有反应，包括该项目将重点关注的三个研究领域：“未经批准的药物/设备的传统临床试验；”比较有效性研究； “质量改进的研究。如果没有这样的指导，可能会因不适合这种不断发展的环境的监督规范而受到不适当的限制。因此，我们期望这项工作是一项重大的首付，这是对急需重新思考如何最好地重新思考人类研究保护措施，以拓宽联邦研究计划和六个项目的卫生系统，以实现该项目的努力，以实现该项目的努力。研究道德，临床试验，比较有效性，质量改善和/或公共政策的专家。概念分析通过（a）未经批准的药物和设备（CTUN）的临床试验的特定示例的丰富案例研究来开发“研究”和“治疗”的构成要素，以定义和表征“研究”和“治疗”的构成元素； （b）比较有效性（CE）研究； （c）质量改进（QI）研究，可以对其进行测试和完善概念分析；目的2：研究这种概念分析的含义，即研究治疗的区别并继续进行的道德和政策目的，特别关注从CTUN，CE和QI Research开发的丰富案例研究； AIM 3：与将CTUN，CE和QI研究进行的研究人员进行实证研究，以（a）列出其领域内的一系列设计和示例，并讨论研究和治疗的本构元如何适用； （b）后来，随着联邦官员的额外纳入，引发了对可行性和适用性的概念和道德分析和政策建议的反应；目标4：基于我们的概念，道德和经验发现，为CTUN，CE和QI研究人员的研究参与者制定政策指导和保护措施，以了解调查人员的知情同意和研究监督。该项目在传统的临床试验，比较有效性研究和质量改进研究的背景下检查了研究治疗界面。通过定期进行的小型协作专家工作组，丰富的案例研究的发展和经验数据收集，我们将起草一个针对研究处理界面的原始概念框架，以及用于研究监督和知情同意的政策建议。