Creating and establishing a sustainable culture of clinical and translational research at an academic cancer center.

Abstract

e23220 Background / Objectives: At the Ellis Fischel Cancer Center (EFCC) at the Univ. of Missouri (MU) School of Medicine (SOM), our recent (2016 - 2020) accurals to interventional oncology clinical trials (CT) have been suboptimal. Hence, the EFCC research leadership undertook a number of initiatives since 2021 to improve the function and productivity of the oncology CT enterprise. The objective of our retrospective review was to determine the impact of our initiatives including improving enrollments to clinical trials. Methods: These major programmatic initiatives have included the following: (1) CT portfolio analysis; (2) faculty survey to assess concerns/ needs related to enrollment; (3) Development of a "One-Pager" list of open CT; (4) Working with faculty leader "champions"; (5) Increasing the number of clinical research staff; (6) Initiation of a monthly "Clinical Trials Working Group (CTWG)" to monitor enrollment to clinical trials, troubleshooting obstacles to accruals and on-going CT portfolio analysis and adjustments; (7) Development of multi-disciplinary "Disease Working Groups" (DWGs) in Breast, GU, GYN-Onc., Lung, GI and CNS cancers to establish a Protocol Review & Monitoring System (PRMS) with the objective of aligning our clinical trials with our patient population; (9) Initiation of a monthly “Investigator Education Workshop” (IEW) to educate our faculty on the conduct of investigator initiated CT and pharma sponsored CT; (10) Initiation of a "Top Enrolling Ceremony" to honor the top enrollers to clinical trials. Results: The analysis of our CT portfolio revealed that in both December 2020 and May 2021, more than half [i.e., 52% (n = 17/33 and n = 13/25, respectively] of our CT had never enrolled a patient in the lifetime of the protocol. Since the implementation of the PRMS in late 2021, we have observed a continual decrease in the status of those clinical trials with “never” any enrollments from a historical average of 52% to 34% in January 2022, to 32% in January 2023 and to 28% in October 2023, p = 0.0173. In addition, implementation of the PRMS also had an immediate significant impact such that only 53% of all of the protocols reviewed by the Protocol Review and Monitoring Committee were approved in 2021 vs. a historical average of 75% from 2018 - 2020. Moreover, between 2021 and 2023, an average total of 82 patients were enrolled to interventional oncology clinical trials vs. the historical average of 42 patients per year from 2016- 2020, representing an overall increase of 95% p = 0.0004. Conclusions: The development and establishment of the PRMS within the last 3 years has had a very positive impact on our clinical trial enterprise at the EFCC by reducing active clinical trials that are not suitable for our patient population and significantly increasing our enrollment to interventional oncology clinical trials. For 2024, we will continue our implementation of the PRMS at the EFCC.