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

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.

“优先考虑 NCI 癌症中心临床试验之前、期间和之后的项目摘要 COVID-19 大流行：描述性和伦理分析” 与其他临床领域相比，国家癌症研究所 (NCI) 癌症中心需要优先考虑试验 在站点级别。然而，癌症中心目前缺乏关于如何最好地确定优先顺序的道德指导 决定。这些决定传统上被视为科学同行评审的问题，而不是 道德判断，而且还没有经过实证研究。鉴于分配 共享的、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 实验室空间和床位——对于谁将从研究参与中受益具有重要影响 科学进步。如果不研究癌症中心如何优先考虑试验，就不可能确定哪些领域 差异、道德挑战和担忧，或者不同方法的优点和缺点。这 像 COVID-19 一样，大流行病为检查癌症中心试验的优先顺序提供了一个令人信服的机会 要求限制面对面的研究活动并减少癌症试验的注册人数，尽管 提出了新的协议，加剧了优先顺序压力。总体而言，生物伦理学作为一个领域已经付出了代价 对试验优先顺序的重视不够，尤其是试验地点的优先顺序，并且没有广泛接受的道德框架 来指导这项任务。然而，文献中正在出现关于试验优先顺序的讨论—— 疫情加速了这一进展，因为各研究中心难以优先考虑大量涌入的 COVID-19 试验。一个 生物伦理学家小组，包括该提案的研究负责人，开发了一个新的框架来巩固 优先考虑 COVID-19 试验，并有可能更广泛地应用于其他疾病领域。这 拟议研究的目标是在此框架和其他资源的基础上建立新的伦理学 癌症中心试验优先顺序模型，使用经验生物伦理学和实施科学方法。 首先，我们将深入采访癌症中心临床研究副主任和其他 知识渊博的线人检查癌症中心（根据其规模、类型和 地区以最大限度地提高观点多样性）在大流行之前和期间优先考虑了试验。尤其， 访谈将探讨道德和实施方面的挑战、感知的成功和失败、期望的 指导、经验教训和未来计划（目标 1）。接下来，我们将比较这些描述性发现 反对拟议的道德框架，以优先考虑 COVID-19 试验，找出缺点、差距和 针对癌症的具体情况进行修订和调整的领域（目标 2）。最后，我们将把这些结合起来 描述性和规范性分析，以开发癌症伦理试验优先顺序的新框架 中心，重点关注实施的可行性（目标 3）。这些目标共同将建立生物伦理学 为癌症中心试验优先政策提供证据基础，以及 NCI 是否以及如何指导 这些决定，同时通过促进伦理试验的优先顺序来促进生物伦理能力建设 负责任的决策者。