Addressing Underperformance in Clinical Trial Enrollments: Development of a Clinical Trial Toolkit and Expansion of the Clinical Research Footprint

解决临床试验注册表现不佳的问题：开发临床试验工具包并扩大临床研究足迹

• 批准号: 10638813
• 负责人: Nina Delaney Wagner-Johnston
• 金额: $ 16.05万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10638813
• 关键词: Academic Medical Centers; Address; Attention; Award; COVID-19 impact; Cancer Center; Caring; Clinical Research; Clinical Trials; Community Health; Comprehensive Cancer Center; Consent; Development; Electronic Mail; Enrollment; Ensure; Goals; Health Educators; Health system; Hematologic Neoplasms; Home; Incentives; Knowledge; Lead; Leadership; Learning; Lymphoma; Newsletter; Oncology; Operations Research; Participant; Patients; Performance; Physicians; Precision medicine trial; Research; Research Proposals; Resources; Site; System; Therapeutic Trials; Time; Update; Work; clinical trial enrollment; diversity and inclusion; feasibility trial; improved; meetings; novel strategies; operation; outreach; patient-level barriers; programs; prospective; research study; tool; web site

Project Summary Both the impacts from COVID-19 as well as the increasing complexities of clinical trials, with a particular emphasis on precision medicine trials, have led to a recent decline in enrollments. This proposal identifies strategies to address the challenges of enhancing clinical trial enrollments in the hematologic malignancies (HM) program at the Sidney Kimmel Comprehensive Cancer Center (SKCCC). The two-pronged approach tackles system barriers and patient barriers. A clinical trial toolkit will be developed to address systems barriers with the goal of minimizing inefficiencies within our research operations program, increasing enrollment, and ultimately creating a clinical trial portfolio that best serves our patients. Components of the toolkit include metrics to ensure feasibility of trials, establish a prioritization queue for resourcing potential studies, trackers for effort and finances, and performance standards. With many patients preferring to receive their care closer to home, while also having access to the same novel approaches offered at academic medical centers, the proposal seeks to extend our clinical research studies to satellite sites. To achieve that end, Dr. Wagner-Johnston addresses strategies to create the necessary research culture to enhance enrollment. Focus will be placed on establishing leadership and providing a collaborative learning culture at the satellite sites. Rational portfolio building at the satellite sites will rely on the same metrics developed as part of the toolkit. Engagement from both physicians and prospective trial participants is essential and this proposal outlines practical approaches to attend to these concerns. Involvement in routine research meetings and recognition of physicians' effort in consenting to trials will incentivize trial participation. Outreach efforts including monthly email newsletters to referring physicians, updates to our HM website, as well as a better tool to identify potential trials for patients are planned. We will extend the ongoing work of community health educators affiliated with projects initiated by the Diversity and Inclusion in Clinical Research Program at SKCCC to include our patients with HM. The outlined research strategy seeks to improve the operational aspects beginning with pre-trial activation through study closure. Attention to increased efficiencies will be essential in bringing needed research to satellite sites. Best practices identified from this project will be readily transferrable to the entire cancer center enterprise at SKCCC and shared with other academic medical centers. As a nationally recognized lymphoma expert with a strong commitment to the NCTN and extensive knowledge in clinical research operations, Dr. Wagner-Johnston is poised to lead these efforts and successfully enhance accruals.

项目摘要 Covid-19的影响以及临床试验的复杂性日益增加，特定的影响 强调精确医学试验，导致入学率下降。该建议确定 解决血液恶性肿瘤（HM）的临床试验入学率的挑战的策略 Sidney Kimmel综合癌症中心（SKCCC）的计划。两管齐的进近铲球 系统障碍和患者障碍。将开发一个临床试验工具包，以解决与系统障碍有关的 在我们的研究操作计划中最大程度地减少效率低下的目标，增加入学率，最终 创建最适合我们患者的临床试验组合。该工具包的组件包括指标以确保 试验的可行性，建立一个优先级的队列，用于资源的潜在研究，努力和财务的跟踪器， 和性能标准。许多患者宁愿接受他们的护理，同时也有 该提议旨在扩展我们的学术医疗中心提供的相同新颖方法 卫星部位的临床研究。为了实现这一目的，瓦格纳 - 约翰斯顿博士解决了策略 创建必要的研究文化以增强入学率。将重点放在建立领导力上 并在卫星站点提供协作学习文化。卫星站点的理性投资组合大楼 将依靠作为工具包的一部分开发的相同指标。医生和潜在的参与 审判参与者是必不可少的，该提案概述了处理这些问题的实用方法。 参与常规研究会议和认可医生同意审判的努力将 激励审判参与。外展工作，包括每月电子邮件通讯，转诊给医生， 计划对HM网站的更新以及计划确定患者潜在试验的更好工具。我们将 扩展社区卫生教育工作者正在进行的工作，隶属于多样性和由多样性和 包括SKCCC的临床研究计划，包括我们的HM患者。概述的研究策略 试图通过研究封闭而从审前激活开始，以改善运营方面。注意 提高效率对于将所需的研究带入卫星站点至关重要。确定的最佳实践 该项目将很容易转移到SKCCC的整个癌症中心企业，并与 其他学术医疗中心。作为全国认可的淋巴瘤专家，对 NCTN和在临床研究操作方面的广泛知识，瓦格纳·约翰斯顿博士准备领导这些 努力并成功增强应计。