PO.CL04.02 · 临床研究
将社区声音融入临床研究：社区科学家在IIT方案审查中的价值
Embedding community voices in clinical research: The value of community scientists in IIT protocol review
作者与单位 Authors & Affiliations
摘要 Abstract
中文摘要
引言：研究者发起的试验(IITs)推动科学发现、检验干预措施并解决未被满足的临床需求；然而，传统的研究流程往往忽视受癌症差异影响最深的社区的观点，导致方案无意中强化了代表性不足群体参与的障碍。社区科学家由患者、照护者、卫生专业人员和社区领袖组成，提供切身经验以确保研究材料、资格标准和招募策略反映受癌症影响人群的现实情况。
方法：Cedars-Sinai癌症中心社区外展与参与(COE)部门识别并培训了11名非专业社区成员担任社区科学家，为他们提供临床试验设计、伦理和知情同意考量以及减轻参与障碍的实用方法等基础知识。COE通过将社区科学家纳入IIT方案审查流程，促进了临床研究者与社区科学家之间的互动，在过去3年中共审查了18项IIT和243项PRMC。为评估社区科学家建议的整合情况和影响，COE调查了14名临床研究者(11名开始填写，5名完全完成)。建议聚焦于性别中立的语言、语言可及性、经济毒性、交通支持、食物不安全、导航和转诊途径以及健康素养。
结果：临床研究者评价COE和社区科学家在为IIT方案提供有价值建议方面有效或非常有效(80%，n=5)，从而提高了代表性不足社区在临床试验中的参与和保留(COE每年转诊1-2名患者)。临床研究者的定性反馈突出了有意义的实践改变，指出社区科学家的建议要么已被采纳，要么正在考虑用于未来研究："我们调整了与患者的讨论方式，以改善试验中的参与和保留"。采纳率最高的建议涉及口译和笔译服务、停车券的提供、经济和社会支持导航，以及向内部和外部社区合作伙伴的热情交接(分别为60%，n=5)。
结论：临床研究者认可与COE和社区科学家合作的价值，并表达了强烈的兴趣，希望扩大社区科学家在早期研究设计、转化和治疗科学、方案制定、成果传播以及参与教育活动方面的参与。这些贡献有意义地增强了研究者发起试验的文化相关性、可行性和包容性。
查看英文原文 English abstract
Introduction: Investigator-Initiated Trials (IITs) advance scientific discovery, test interventions, and address unmet clinical needs; however, traditional research processes often overlook the perspectives of communities most affected by cancer disparities, leading to protocols that unintentionally reinforce barriers to participation among underrepresented groups. Community Scientists , comprising patients, caregivers, health professionals, and community leaders, offer lived expertise to ensure that study materials, eligibility criteria, and recruitment strategies reflect the realities of the populations affected by cancer.
Methods: Cedars-Sinai Cancer Center Community Outreach & Engagement (COE) identified and trained 11 lay community members as Community Scientists, equipping them with foundational knowledge in clinical trial design, ethical and informed consent considerations, and practical approaches to mitigating participation barriers. COE facilitated engagement between clinical researchers and Community Scientists by integrating them into the IIT protocol review process, resulting in 18 IITs and 243 PRMC reviewed in the past 3 years. To assess the integration and impact of Community Scientist recommendations, COE surveyed 14 clinical researchers (11 initiated, 5 fully completed). Recommendations focused on gender-neutral language, language accessibility, financial toxicity, transportation support, food insecurity, navigation and referral pathways, and health literacy.
Results: Clinical researchers rated COE and Community Scientists as effective or very effective (80%, n=5) in providing valuable recommendations on IIT protocols, resulting in increased participation and retention of underrepresented communities in clinical trials (1-2 patient referrals yearly from COE). Qualitative feedback from clinical researchers highlighted meaningful practice changes, highlighting that Community Scientists' recommendations were either already adopted or being considered for future studies: “We adjusted our discussion with patients to improve engagement and retention in trials”. Adoption was highest for recommendations related to interpretation and translation services, parking voucher availability, financial and social support navigation, and warm handoffs to internal and external community partners (60%, n=5, respectively).
Conclusion: Clinical researchers recognized the value of collaboration with COE and Community Scientists, and expressed a strong interest in expanding Community Scientists' involvement in early-stage study design, translational and therapeutic science, protocol development, dissemination of findings, and participation in educational activities. The contributions meaningfully enhance the cultural relevance, feasibility, and inclusivity of investigator-initiated trials.
利益披露 Disclosure
R. Balingit, None..
L. Barajas, None..
O. Arroyo, None..
Z. Surani, None.