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：挑战区域：生物伦理挑战主题：02-OD（OSP）-105* 每年有200多万患有癌症、心脏病、传染病、糖尿病、神经系统疾病和其他疾病的美国人参加美国的临床研究。对于这些患者-受试者中的许多人来说，他们及其医生将参与视为治疗或应对其医疗状况的一种手段。此外，在未来几年中，向比较有效性研究和质量改进研究注入数十亿美元，确保很快就会有更多的患者接受以某种方式与临床和卫生服务系统研究相结合的护理。事实上，人们越来越认识到，只有不断研究医疗干预和实践的结果，才能实现高价值的医疗保健。因此，研究方法和资金正在迅速变化，以满足这一实际需要。.这种不断变化的环境所面临的挑战是使传统的研究伦理范式适应这种新的研究和治疗界面范式，其中研究和治疗越来越多地（但在不同程度上）融入到一些人所说的总体学习环境中。该项目旨在开始填补研究与治疗日益融合所造成的研究伦理方面的知识和政策空白。迫切需要有用的政策指导，以应对跨研究方法的研究和治疗的综合性质，包括本项目将重点关注的三个研究领域：“未经批准的药物/器械的传统临床试验”;“比较有效性研究”;“质量改进研究”。如果没有这种指导，不适合这一不断变化的背景的监督规范可能会不适当地阻碍急需的研究。因此，我们希望这项工作是一个重要的首付款，急需重新思考如何最好地为不断扩大的联邦研究计划和未来的卫生系统制定人类研究保护措施，其中研究和治疗日益交织在一起。该项目将通过一个由研究伦理、临床试验、比较有效性、质量改进和/或公共政策方面的六名专家组成的核心小组正在进行的协作会议来完成其工作。通过小组和核心小组的互动，丰富的案例研究和经验数据收集的发展，该项目将产生一个概念分析，认为研究治疗接口，而不是完全分离，并将产生相关的政策指导和保障我们不断发展的研究议程。该项目的目标包括：目标1：通过对以下具体实例进行丰富的案例研究，进行明确的概念分析，界定和描述“研究”和“治疗”的构成要素：（a）未经批准的药物和器械的临床试验;（B）比较有效性研究;以及（c）质量改进研究，可据此检验和完善概念分析;目标2：审查这一概念分析对道德和政策目的的影响，研究与治疗的区别已经并将继续被置于道德和政策目的之下，目标3：与进行CTUn、CE和QI研究的调查人员一起进行实证研究，以（a）列出其领域内的一系列设计和实例，并讨论研究和治疗的构成要素如何应用;以及（B）随后，在联邦官员的参与下，征求对概念和道德分析草案以及政策建议的可行性和适用性的反应;目标4：根据我们的概念，道德和实证研究结果，为CTUn，CE和QI研究中的研究参与者制定政策指导和保障措施，具体到研究者，知情同意和研究监督。本项目在传统临床试验、比较有效性研究和质量改进研究的背景下考察研究-治疗界面。通过一个小型的合作专家工作组的定期互动，丰富的案例研究和经验数据收集的发展，我们将起草一个原始的概念框架的研究-治疗接口，以及研究监督和知情同意的政策建议。