Improving Clinical Trial Cycle Times through Increased Partnership

1. Improving Clinical Trial Cycle Times through Increased Partnership Nancy Trapp Clinical Operations Team Leader-Regulatory, Eli Lilly and Company • Current State • In general, the pharmaceutical industry aims for the cycle time between site selection to the time a site is deemed ready to enroll a patient to take 90 days for private/independent sites and 120 days for academic sites. • Eli Lilly and Company (Lilly) is currently performing at an average of approximately 125 days for academic sites becoming regulatory ready. • Therefore, improving the regulatory readiness timelines of academic sites that participate in clinical research trials may decrease the time it takes to make important clinical options available to patients. Johns Hopkins/Lilly Six Sigma – Potential Root Causes for Delayed Cycle Times Johns Hopkins/Lilly Six Sigma Tips and Tricks • Establish single point of contact (sponsor and academic institution) • Understand each other’s processes and required internal reviews (process, timing, requirements) and expectations • Complete a Template / Master Letter of Confidentiality • Master Letter of Agreement • Standard template for non-protocol pieces of ICD and ‘usual’ procedure language • Site budget out of Lilly within 5 days and accompanied by protocol • Continued technological advancements and IT solutions • Consistent and frequent communications and status updates • Lack of communication about where the study is in the process (at academic site and with the sponsor) • Lots of wait time within and between steps • Unclear contact person academic site and/or sponsor • Lack of process definitions and lack of knowledge about process • Lack of access to information • Lots of hand-offs Johns Hopkins/Lilly Six Sigma Improvements • Improved Communication • Lilly CRA will communicate to JH-CRO and JH-ORA when PI is contacted and signs Confidentiality Agreement; Developed Communication Template to use throughout the process • Partner JH with Lilly-Budget Office and Lilly-Contract Office to resolve template issues and overhead • Agreed on use of .pdf files and signatures in any order on study amendments to Master Service Agreement • Improve the CRC Process / Tracking System • Lilly – Investigator Portal – Goes live throughout 2008 • JH – CRMS – Goes live July 1, 2008 and will have many features including a dashboard • Help for the PI • Dashboard in CRMS • Standard Confidentiality Agreement • Standard Master Service Agreement • Standard Informed Consent • Standard costs for Pharmacy, SAC Lab, and Professional fees Cycle Times Academic Institution Metrics: Cycle Time of CTRB Shipment Date to ICD Approval Date (median number of days) Academic Institution Metrics: Cycle Time of Site Selection Date to LOA Approval Date (median number of days) Sponsor: Mike Amey, JH/Chris Davis, LLY Project #: 4279 Black Belt: Kathy Ann Lawrence Country: USA Case Study: Johns Hopkins/Lilly Six Sigma – Oncology Improving Regulatory Readiness Timelines • Problem • Multiple review boards and serial process steps lead to lengthy site readiness activities when partnering with academic research centers.   • Johns Hopkins/Lilly has median values for Site Readiness (CTRB shipped to CT ordered) at 169 days.  • Goal • Our goal is to reduce variability and cycle times within the site readiness process for Johns Hopkins research sites by 15% (24 days). • Root Causes • Lack of communication about where the study is in the process • Lots of wait time within and between steps • Unclear contact person at Johns Hopkins and/or Lilly • Solutions • Improved communication tools • Improve Clinical Review Committee process and tracking tools at Johns Hopkins • Help for the Primary Investigator and Johns Hopkins staff Green = Quick WinGrey = Improvement with SimulationBlack = Future Benefit Confirm120 – The Process Flow Map Data on file at Eli Lilly and Company Data on file at Eli Lilly and Company Academic Institution Metrics: Cycle Time of CTRB Shipment to Regulatory Ready Date (median number of days) • Project Approach • Champions, sponsors, and team members from Johns Hopkins and Lilly. • Two-day face-to-face meetings in Measure, Analyze, and Improve Six Sigma sessions at alternating facilities. • Openness and trust in the partnership to put it all on the table for discussion and improvement. • Internal communication within each partner and external via publication. • Expected Results • A 37% reduction in regulatory readiness cycle time (from a median of 169 days to 107 days). • Validation • Lilly to provide list of trials in Oncology and other therapeutic areas. • Johns Hopkins will also measure other sponsor improvements in Oncology. Pilot and Quick Win Goals Potential Solution Identification Data on file at Eli Lilly and Company In 3 hours, the Johns Hopkins / Lilly team: Academic Institution Metrics: Percentage of Sites Declared Regulatory Ready by Date of Planned FPV Control ChartAcademic Institutions Control Chart of CTRB Ship to Reg Ready • Brainstormed 69 different possible ideas • Grouped the 69 ideas into 5 categories • Developed 13 possible improvements • Prioritized and combined the 13 possible improvements into 4 solutions with teams to work on them. Improving the regulatory readiness timelines of academic sites that participate in clinical research trials may decrease the time it takes to make important clinical options available to patients. Data on file at Eli Lilly and Company Data on file at Eli Lilly and Company CTSA Clinical Research Management Workshop