Abramson Cancer Center Support Grant.
艾布拉姆森癌症中心支持拨款。
基本信息
- 批准号:10367691
- 负责人:
- 金额:$ 16.25万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AreaAttentionAwardBedsBioethicsBioethics ConsultantsCOVID-19COVID-19 pandemicCancer BurdenCancer CenterCancer Center Support GrantCancer ModelClinicalClinical ResearchClinical TrialsCommunitiesCrowdingDecentralizationDecision MakingDevelopmentDiseaseEducational CurriculumEnrollmentEthical AnalysisEthicsFailureFosteringFutureGoalsIndividualInfrastructureInterviewJudgmentKnowledgeLeadLightLiteratureMalignant NeoplasmsMethodsMissionMonitorNational Cancer InstituteParentsPatientsPeer ReviewPersonsPhasePoliciesProcessProtocols documentationQualitative MethodsRecommendationResearchResearch ActivityResearch PersonnelResearch PriorityResource SharingResourcesSiteStructureSystemUnderrepresented PopulationsVariantWorkanticancer researchbaseeligible participantevidence basehealth economicsimplementation barriersimplementation scienceinformantnovelpandemic diseasepeerpressurerecruitsuccessuptake
项目摘要
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.
“NCI癌症中心临床试验的优先排序”项目总结
项目成果
期刊论文数量(0)
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专利数量(0)
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{{ truncateString('ROBERT H VONDERHEIDE', 18)}}的其他基金
Immunotherapy and Tumor Microenvironment in HIV/AIDS Cancer Patients
HIV/艾滋病癌症患者的免疫治疗和肿瘤微环境
- 批准号:
10249752 - 财政年份:2019
- 资助金额:
$ 16.25万 - 项目类别:
non-AIDS defining cancers (NADCs) among aging HIV+ individuals
老年艾滋病毒感染者中的非艾滋病定义癌症(NADC)
- 批准号:
10249743 - 财政年份:2019
- 资助金额:
$ 16.25万 - 项目类别:
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10005190 - 财政年份:2017
- 资助金额:
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