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日益复杂，特别是 强调精确医学试验，导致最近注册人数下降。该提案确定了 应对提高血液系统恶性肿瘤（HM）临床试验入组率挑战的策略 Sidney Kimmel综合癌症中心（SKCCC）双管齐下的方法 系统障碍和患者障碍。将开发一个临床试验工具包， 我们的目标是最大限度地减少我们的研究运营计划中的低效率，增加入学率，并最终 创建一个最适合我们患者的临床试验组合。该工具包的组成部分包括各种指标，以确保 试验的可行性，建立一个优先队列，为潜在的研究提供资源，跟踪工作和资金， 和业绩标准。许多患者更喜欢在离家更近的地方接受护理， 获得学术医疗中心提供的相同的新方法，该提案旨在扩大我们的 临床研究到卫星站点。为了实现这一目标，瓦格纳-约翰斯顿博士提出了以下战略， 创造必要的研究文化，以提高入学率。重点将放在建立领导地位上 并在卫星站点提供协作学习文化。在卫星站点建立合理的组合 将依赖于作为工具包一部分开发的相同指标。医生和潜在客户的参与 审判参与者至关重要，本提案概述了处理这些关切的实际办法。 参与常规的研究会议和认可医生在同意试验方面的努力， 鼓励参与试验。外联工作，包括每月向转诊医生发送电子邮件通讯， 我们计划更新我们的HM网站，以及一个更好的工具来识别潜在的患者试验。我们将 扩大与多样性发起的项目有关的社区健康教育工作者正在进行的工作， 纳入SKCCC的临床研究计划，以纳入我们的HM患者。研究战略概述 从试验前启动到研究结束，寻求改进操作方面。注意 提高效率对于将所需的研究工作带到卫星站点至关重要。确定的最佳做法 从这个项目中，将很容易转移到整个癌症中心的企业在SKCCC和共享 其他学术医疗中心作为全国公认的淋巴瘤专家， NCTN和临床研究操作的广泛知识，瓦格纳-约翰斯顿博士准备领导这些 努力并成功地提高应计利润。