Abramson Cancer Center Support Grant.

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.