Abramson Cancer Center Support Grant.

《美国国立卫生研究院癌症中心临床试验优先顺序》项目总结 新冠肺炎大流行：描述性和伦理学分析 与其他临床领域不同，国家癌症研究所(NCI)癌症中心被要求优先进行试验 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伦理指导 决定。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，而且还没有经过实证研究。这是关于分配给 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 实验室空间和床位-对谁将从研究参与和 科学进步。如果不研究癌症中心如何确定试验的优先顺序，就不可能确定 差异、道德挑战和关切，或不同方法的优点和缺点。这个 大流行为检查癌症中心试验优先顺序提供了一个令人信服的机会，如新冠肺炎 要求限制面对面的研究活动，并减少癌症试验的登记人数，即使有 提出了新的协议，加大了确定优先顺序的压力。总体而言，生物伦理学作为一个领域已经取得了成效 对审判优先次序的重视不足，特别是按地点，而且没有得到广泛接受的道德框架 来指导这项任务。然而，在文献中出现了关于试验优先顺序的讨论- 疫情加速了这一进展，因为各网站都在努力确定涌入的新冠肺炎试验的优先顺序。一个 一组生物伦理学家，包括这项提议的研究带头人，开发了一个新的框架，以巩固 优先考虑新冠肺炎试验，有可能更广泛地适用于其他疾病领域。这个 拟议研究的目标是建立在这一框架和其他资源的基础上，以产生新的伦理 癌症中心试验优先排序模型，使用经验生命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，以检查癌症中心(根据其规模、类型和 (该区域为最大限度地扩大观点多样性)将大流行前和大流行期间的试验列为优先事项。特别是， 访谈将探讨道德和实施挑战、感知的成功和失败，以及期望的 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 对照建议的道德框架确定新冠肺炎试验的优先顺序，找出缺点、差距和 为癌症的具体情况修订和适应的领域(目标2)。最后，我们将结合这些 描述性和规范性分析为癌症伦理试验优先顺序制定新的框架 中心，重点是实施的可行性(目标3)。这些目标将共同构建生命伦理学。 为癌症中心试验优先顺序政策提供信息的证据基础，以及NCI是否以及如何指导 这些决定有助于通过以下方式确定伦理试验的优先顺序，从而促进生物伦理能力建设 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.