Abramson Cancer Center Support Grant.

“在NCI癌症中心进行临床试验之前、期间和之后的优先次序”项目总结 2019冠状病毒病大流行：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 在现场一级。然而，癌症中心目前缺乏如何最好地确定优先顺序的伦理指导 决策这些决定传统上被视为科学同行审查的问题，而不是 道德判断，它们还没有被实证研究。这是因为， 共享有限的研究机构资源-从合格的参与者和现有的研究人员， 实验室空间和床位-对谁能从研究参与中受益具有重要意义， 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 差异、道德挑战和关切，或不同方法的优缺点。的 大流行提供了一个令人信服的机会，检查癌症中心的试验优先次序，因为COVID-19 要求限制面对面的研究活动，减少癌症试验的注册人数， 提出了新的议定书，加大了优先次序的压力。总的来说，生物伦理学作为一个领域， 对试验优先顺序关注不够，尤其是研究中心，没有广泛接受的伦理框架 来指导这项任务。然而，在文献中出现了关于审判优先顺序的讨论- 而大流行加速了这一进程，因为各研究中心努力优先处理COVID-19试验的涌入。一 一组生物伦理学家，包括这项提议的研究负责人，开发了一个新的框架， 并优先考虑COVID-19试验，有可能更广泛地适用于其他疾病领域。的 拟议研究的目标是建立在这一框架和其他资源，以产生一个新的伦理 癌症中心试验优先级模型，使用经验生物伦理学和实施科学方法。 首先，我们将对癌症中心的临床研究副主任和其他 知识渊博的知情人，以检查如何癌症中心（根据其规模，类型和 为了最大限度地扩大观点的多样性，各区域的检察官和检察官都在大流行病之前和期间优先进行审判。特别是， 访谈将探讨道德和实施方面的挑战，感知的成功和失败， 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 对照拟议的伦理框架，确定COVID-19试验的优先次序，找出缺点、差距， 根据癌症的具体情况进行修订和调整的领域（目标2）。最后，我们将联合收割机 描述性和规范性分析，以开发癌症伦理试验优先级的新框架 中心，重点是实施的可行性（目标3）。这些目标将共同构建生物伦理学 为癌症中心试验优先级政策提供信息的证据基础，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次序， 负责任的决策者。

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.