QLTI-21. STREAMLINING THE STUDY INTAKE PROCESS AT THE CANCER CLINICAL AND TRANSLATIONAL RESEARCH OFFICE (CCTRO)

Abstract Challenges in the Protocol Intake/Activation process at the Henry Ford Cancer Center, particularly during the budget negotiation and coverage analysis (CA) phases, hamper operational efficiency and financial prospects. This study aimed to improve budget time and process efficiency. Process flow mapping, Value Stream Mapping (VSM), and cause-effect analysis using a fishbone diagram were used to identify and analyze key bottlenecks, focusing on the budget negotiation and CA phases. Budget negotiation took an average of 121.5 days in 2023 due to multiple procedures and a lack of standardized practices. Delays ranged from 127.75 days in August to a low of 69.84 days in November of 2023. The budget build process averaged 13.31 days, with an additional 7.57 days for approval, totaling 20.89 days. The CA phase had an average cycle time of 10.82 days (range 2-10 days). To improve approval times, it was recommended to implement an Electronic Document Management System to automate routing, signing, and tracking of budget and CA-related documents, standardized budget templates to streamline negotiations, a detailed electronic checklist to streamline task lists for document collection and budget negotiation, automated reminders for internal and external stakeholders to ensure timely submission of necessary documents, and timely submission policies enforced by a dedicated finance member on committees. Newly developed Key Performance Indicators (KPIs) such as ‘time to collect documents,’ ‘time between committees,’ and ‘time for budget negotiation process,’ along with a dual tracking system in Excel, were proposed to monitor and improve these metrics. The recommendations are expected to significantly enhance the efficiency of the Protocol Intake/Activation process. By reducing the budget negotiation phase to less than 60 days and optimizing the CA process, faster study initiation, better resource utilization, and improved responsiveness to research opportunities will be achieved. This study underscores the critical need to address operational challenges in clinical trial management to enhance CCTRO’s capability to conduct timely and effective research.