PO.RSP01.01 · 监管科学与政策
一项混合方法评估：考察多层次障碍与促进因素以指导在大型综合癌症中心推进公平临床试验入组的实施策略
A mixed-methods evaluation of multilevel barriers and facilitators to inform implementation strategies for advancing equitable clinical trial accrual in a large comprehensive cancer center
作者与单位 Authors & Affiliations
摘要 Abstract
中文摘要
引言：在系统、医务人员和患者层面的多层次干预和实施策略可支持临床试验入组。本研究考察一所大型综合癌症中心临床试验入组的流程、促进因素和障碍，以指导干预并识别实施策略机会，从而维持公平的试验参与。
方法：在Consolidated Framework for Implementation Research（CFIR）的指导下，我们采用混合方法设计，于2024年9月至2025年4月对肿瘤内科和血液科医务人员进行问卷调查和访谈。USC Norris Comprehensive Cancer Center主院区及卫星诊所的医务人员完成了问卷和深入访谈，评估其在试验入组方面的经历，包括对临床试验的信念、态度和知识；工作流程和组织文化；以及患者障碍。问卷数据采用描述性统计进行汇总，访谈文本采用CFIR进行编码以识别关键实施决定因素。
结果：在问卷参与者（n=49）中，69%在主院区执业，31%在卫星诊所执业。尽管96%认为临床试验对患者治疗很重要，但45%表示在试验入组知识方面存在不足。内部环境障碍因研究地点而异，主院区74%的医务人员相比卫星诊所20%的医务人员指出临床试验的人员支持有限（p=0.003）。外部环境障碍差异较小，主院区64%和卫星诊所53%的医务人员报告语言翻译资源有限（p=0.44）。定性访谈（n=15）强化了这些CFIR领域；研究协调员可及性有限、时间限制和语言翻译成为关键障碍。医务人员的积极性以及对试验入组培训的兴趣被确定为优化试验入组的关键促进因素。
讨论：优化临床试验招募的障碍包括医务人员知识不足、人员配置限制和语言资源不足，所有这些都可能制约公平入组。尽管存在这些挑战，医务人员仍有积极性向其患者提供试验机会。推进入组需要与医务人员和诊所团队共同设计解决方案，以应对系统层面和患者层面的障碍。有针对性的干预措施——如医务人员培训、增强试验信息可及性以及翻译服务——可能改善包容性入组。
查看英文原文 English abstract
Introduction: Multilevel interventions and implementation strategies at the system, provider, and patient levels can support clinical trial enrollment. This study examines processes, facilitators, and barriers to clinical trial enrollment across a large comprehensive cancer center to inform interventions and identify opportunities for implementation strategies to sustain equitable trial participation.
Methods : Guided by the Consolidated Framework for Implementation Research (CFIR), we used a mixed-methods design to survey and interview oncology and hematology providers from September 2024 to April 2025. Providers at USC Norris Comprehensive Cancer Center's main medical campus and satellite clinics completed surveys and in-depth interviews that assessed their experiences with trial enrollment, including beliefs, attitudes, and knowledge about clinical trials; workflow and organizational culture; and patient barriers. Survey data were summarized using descriptive statistics, and interview transcripts were coded using CFIR to identify key implementation determinants.
Results: Among survey participants (n=49), 69% practiced at the main campus and 31% at satellite clinics. Although 96% viewed clinical trials as important to patient care, 45% indicated gaps in knowledge of trial accrual. Inner setting barriers differed by site, with 74% of providers at the main campus compared to 20% at satellite clinics citing limited staffing support for clinical trials (p=0.003). Outer setting barriers showed less variation, with 64% of providers at the main campus and 53% at satellite clinics reporting limited language translation resources (p=0.44). Qualitative interviews (n=15) reinforced these CFIR domains; limited access to research coordinators, time constraints, and language translation emerged as key barriers. Provider motivation and interest in trials accrual training were identified as key facilitators to optimize trial enrollment.
Discussion : Barriers to optimal clinical trial recruitment include gaps in provider knowledge, staffing limitations, and insufficient language resources, all of which may constrain equitable enrollment. Despite these challenges, providers remained motivated to offer trials to their patients. Advancing enrollment requires co-designed solutions with providers and clinic teams to address system level and patient barriers. Targeted interventions - such as provider training, enhanced access to trial information, and translation services - may improve inclusive enrollment.
利益披露 Disclosure
M. Gill, None..
S. Iqbal, None..
V. Kodancha, None..
E. Friedman, None..
D. L. Hanna, None..
C. Hughes-Halbert, None..
A. El-Khoueiry, None..
J. Tsui, None.