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

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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.