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

项目摘要 新冠肺炎的影响以及临床试验的日益复杂，尤其是 对精确医学试验的重视，导致了最近入学人数的下降。这份提案确定了 应对提高恶性血液病(HM)临床试验登记人数的挑战的策略 西德尼·基梅尔综合癌症中心(SKCCC)的项目。双管齐下的方法解决了 制度障碍和患者障碍。将开发临床试验工具包，以解决系统障碍 我们的目标是将研究运营计划中的低效降至最低，增加注册人数，并最终 创建最好地为我们的患者服务的临床试验组合。工具包的组件包括指标以确保 试验的可行性，建立为潜在研究提供资源的优先队列，努力和资金的跟踪器， 和性能标准。许多患者更愿意在离家更近的地方接受治疗，同时也有 使用学术医疗中心提供的相同新方法，该提案旨在扩大我们的 将临床研究成果转移到卫星站点。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招生人数。重点将放在建立领导力上 并在卫星站点提供协作学习文化。卫星站点上的Rational投资组合构建 将依赖于作为工具包一部分开发的相同指标。来自医生和潜在客户的参与度 试验参与者至关重要，这项提案概述了处理这些关切的实际办法。 参与常规研究会议并认可医生在同意试验方面的努力将 鼓励参与试验。外展工作，包括每月向推荐医生发送电子邮件时事通讯， 我们计划更新HM网站，以及一个更好的工具来确定患者的潜在试验。我们会 扩展社区健康教育者正在进行的工作，这些教育者隶属于多样性和 纳入SKCCC的临床研究计划，以纳入我们的HM患者。概述的研究战略 寻求改善业务方面，从审前启动开始，通过研究结束。注意 提高效率对于将所需的研究带到卫星站点至关重要。确定的最佳做法 来自该项目的信息将很容易地转移到SKCCC的整个癌症中心企业，并与 其他学术医疗中心。作为一名国家公认的淋巴瘤专家，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 努力并成功地提高了应计利润。

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.