Abramson Cancer Center Support Grant.

艾布拉姆森癌症中心支持拨款。

• 批准号: 10367691
• 负责人: ROBERT H VONDERHEIDE
• 金额: $ 16.25万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-13 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10367691
• 关键词: Area; Attention; Award; Beds; Bioethics; Bioethics Consultants; COVID-19; COVID-19 pandemic; Cancer Burden; Cancer Center; Cancer Center Support Grant; Cancer Model; Clinical; Clinical Research; Clinical Trials; Communities; Crowding; Decentralization; Decision Making; Development; Disease; Educational Curriculum; Enrollment; Ethical Analysis; Ethics; Failure; Fostering; Future; Goals; Individual; Infrastructure; Interview; Judgment; Knowledge; Lead; Light; Literature; Malignant Neoplasms; Methods; Mission; Monitor; National Cancer Institute; Parents; Patients; Peer Review; Persons; Phase; Policies; Process; Protocols documentation; Qualitative Methods; Recommendation; Research; Research Activity; Research Personnel; Research Priority; Resource Sharing; Resources; Site; Structure; System; Underrepresented Populations; Variant; Work; anticancer research; base; eligible participant; evidence base; health economics; implementation barriers; implementation science; informant; novel; pandemic disease; peer; pressure; recruit; success; uptake; Area; Attention; Award; Beds; Bioethics; Bioethics Consultants; COVID-19; COVID-19 pandemic; Cancer Burden; Cancer Center; Cancer Center Support Grant; Cancer Model; Clinical; Clinical Research; Clinical Trials; Communities; Crowding; Decentralization; Decision Making; Development; Disease; Educational Curriculum; Enrollment; Ethical Analysis; Ethics; Failure; Fostering; Future; Goals; Individual; Infrastructure; Interview; Judgment; Knowledge; Lead; Light; Literature; Malignant Neoplasms; Methods; Mission; Monitor; National Cancer Institute; Parents; Patients; Peer Review; Persons; Phase; Policies; Process; Protocols documentation; Qualitative Methods; Recommendation; Research; Research Activity; Research Personnel; Research Priority; Resource Sharing; Resources; Site; Structure; System; Underrepresented Populations; Variant; Work; anticancer research; base; eligible participant; evidence base; health economics; implementation barriers; implementation science; informant; novel; pandemic disease; peer; pressure; recruit; success; uptake

Project Summary for “Prioritizing Clinical Trials at NCI Cancer Centers Before, During, and After the COVID-19 Pandemic: A Descriptive and Ethical Analysis” In contrast to other clinical areas, National Cancer Institute (NCI) Cancer Centers are required to prioritize trials at the site level. However, Cancer Centers currently lack ethics guidance for how best to make prioritization decisions. These decisions have traditionally been viewed as a matter of scientific peer review, rather than as ethical judgments, and they have not been empirically studied. This is concerning given that allocation of shared, limited institutional resources for research – from eligible participants and available research staff to lab space and beds – has critical implications for who stands to benefit from research participation and scientific progress. Without studying how Cancer Centers prioritize trials, it is not possible to identify areas of variation, ethical challenges and concerns, or the strengths and weaknesses of different approaches. The pandemic offers a compelling opportunity to examine Cancer Center trial prioritization, as COVID-19 demanded restrictions on in-person research activities and reduced cancer trial enrollments, even as many new protocols were proposed, intensifying prioritization pressures. Overall, bioethics as a field has paid insufficient attention to trial prioritization, especially by sites, and there is no widely-accepted ethics framework to guide this task. There is, however, emerging discussion of trial prioritization developing in the literature – and the pandemic has accelerated this progress, as sites struggled to prioritize an influx of COVID-19 trials. A group of bioethicists, including the study lead on this proposal, developed a novel framework for consolidating and prioritizing COVID-19 trials, with the potential for broader applicability to other disease areas. The objective of the proposed research is to build on this framework and other resources to produce a new ethics model for Cancer Center trial prioritization, using empirical bioethics and implementation science methods. First, we will use in-depth interviews with Cancer Center Associate Directors of Clinical Research and other knowledgeable informants to examine how Cancer Centers (selected on the basis of their size, type, and region to maximize diversity of perspective) have prioritized trials before and during the pandemic. In particular, interviews will probe ethical and implementation challenges, perceived successes and failures, desired guidance, and lessons and plans for the future (Aim 1). Next, we will compare these descriptive findings against the proposed ethics framework for prioritizing COVID-19 trials, identifying shortcomings, gaps, and areas for revision and adaptation for the specific context of cancer (Aim 2). Finally, we will combine these descriptive and normative analyses to develop a novel framework for ethical trial prioritization by Cancer Centers, with a focus on feasibility of implementation (Aim 3). Together, these aims will build the bioethics evidence base to inform Cancer Center trial prioritization policy, as well as whether and how NCI should guide these decisions, while contributing to bioethics capacity building by facilitating ethical trial prioritization by responsible decision-makers.

项目摘要“优先在NCI癌症中心进行临床试验的优先级，此前和之后 COVID-19大流行：一种描述性和道德分析” 与其他临床区域相比，国家癌症研究所（NCI）癌症中心需要优先考虑试验 在现场级别。但是，目前癌症中心缺乏道德指导，如何最好地优先考虑 决定。传统上，这些决定被视为科学同行评审的问题，而不是 道德法官，他们没有经验研究。鉴于分配 共享，有限的研究机构资源 - 从合格的参与者和可用的研究人员到 实验室空间和床 - 对谁从研究参与中受益和 科学进步。如果不研究癌症中心如何优先级试验，则无法确定 变化，道德挑战和关注，或不同方法的优势和缺点。 大流行提供了一个令人信服的机会来检查癌症中心试验优先级，如Covid-19 要求对面对面研究活动的限制并减少癌症试验入学率，即使 提出了新协议，加强了优先压力。总体而言，生物伦理学作为一个领域 对试验优先级的关注不足，尤其是网站，并且没有广泛的道德框架 指导此任务。但是，关于文献中正在发展的审判优先级的新兴讨论 - 大流行已经加快了这一进展，因为站点努力优先考虑COVID-19试验的影响。一个 一组生物伦理学家，包括该提案的研究负责人，开发了一个新颖的框架来合并 并优先考虑COVID-19试验，并有可能更广泛地适用于其他疾病领域。 拟议的研究的目的是建立在该框架和其他资源的基础上，以产生新的道德规范 使用经验生物伦理学和实施科学方法的癌症中心试验优先级模型。 首先，我们将对临床研究和其他癌症中心副总监进行深入的访谈 知识渊博的信息以检查癌症中心（根据其规模，类型和 在大流行之前和期间，具有最大化的视角多样性的区域已优先进行试验。尤其， 访谈将探讨道德和实施挑战，感知的成功和失败，期望 指导，未来的课程和计划（AIM 1）。接下来，我们将比较这些描述性发现 违反提议的道德框架，以优先考虑COVID-19试验，确定缺点，差距和 修订和适应癌症特定环境的领域（AIM 2）。最后，我们将结合这些 描述性和正常分析以开发一个新的癌症伦理试验优先级框架 中心，重点是实施可行性（AIM 3）。这些目标将共同建立生物伦理学 向癌症中心试验优先级政策的证据基础，以及NCI是否应指导 这些决定，同时通过促进通过促进道德审判优先级的生物伦理能力来建设 负责任的决策者。