Accelerating cancer research trial startup in the community setting: A quality-improvement study.

Abstract

11066 Background: There is a large variation in activation times for cancer clinical trials, delaying the opportunity for patients to benefit from cutting edge treatments. Academic medical centers typically take longer to activate a clinical trial as compared to community settings. Some academic medical centers have adopted quality improvement processes to reduce clinical trial start-up time. Our center, TriHealth Cancer & Blood Institute (TCBI) in the SW Ohio community has also adopted quality improvement processes to further reduce startup time within our oncology research group. Methods: This study encompassed July 2022-June 2023, with baseline data drawn from January 2021 to December 2021 prior to the study period which revealed a mean clinical trial start-up time of 116 days. The research group used a swim-lane process to define the typical process & stakeholders for clinical activation time at our institution prior to the study time. Our group identified three major areas with significant lag-time - contracts, budgets, & IRB/ICF - with the overarching root cause for delays due to lack of organizational process & expertise in these major areas. Using Plan-Do-Study-Act (PDSA), we instituted interventions, which included utilizing a central IRB, identifying a responsible member with extensive research budgeting to review research study budgets, & identified a responsible member with extensive contracts review & negotiations working with Central Legal throughout the contracts negotiation process with sponsor(s). Results: During this 12-month study time, our center demonstrated a 44% reduction in trial start up time (141 days to 79 days), while at the same time doubling the number of active trials. This process change resulted in sustainability that carried into 2023, further reducing start-up time to 70 days. In 2021, we opened 6 studies and after adoption of these process improvements (2022) we doubled the number of studies by 117%, while opening 67% more in 2023 than in 2021. The ability to open more studies has allowed us to shift patient enrollment to more investigational trials while increasing treatment enrollment from 2022 to 2023 by 24%. Through process improvement, more treatment studies are open & available for our community. Conclusions: By implementing interventions to streamline clinical trial activation time, our center was able to significantly & sustainably reduce the time required to start a clinical trial in our community health system in a 12-month period, resulting in our ability to initiate more clinical trials. As a result, more treatment trial patients were able to be enrolled in these clinical trials at TCBI, with the hope of improved outcomes. We anticipate that further adoption of just-in-time studies may help to decrease this activation time further. [Table: see text]