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  • The variability with the approval of ICDs at an academic institutions have been less variable over the past year at Lilly due to: Enhanced project management during the regulatory readiness phase Enhanced ICD negotiation skills with the MRA Minimally acceptable language regarding required Lilly language. Academic institutions typically have multiple layers of trial review. There will be variability with the exact requirements by therapeutic area. Oncology trials tend to have at least (2) protocol review board meetings, as well additional boards as required by the trial (for example, a radiation board may be required to review the protocol). Academic institutions do contract IRB services with central IRBs, but their local board will still have some sort of oversight of industry sponsored trials. Keys to ICD negotiation with academic institutions: Identify the exact IRB review and approval process for the institution. Is budget or clinical trial agreement required to be approved prior to IRB submission/approval? Will clinical trial agreement be delayed until the IRB approval has been issued. Ensure that the protocol and all requirements are submitted to the earliest PRC meeting in order to prevent any additional delays in review. Identify the deadline for the response to all inquiries made by the PRC or IRB to ensure that the protocol is not “bumped” to the next month as a result of missing a response deadline.
  • Key to point out that this metrics is measured from the date of site selection by Lilly. The budget/contract department can begin working on the budget/contract for the site even before the site receives their Clinical Trial Records Binder. This is why the median cycle time for the LOA approval is noted to be longer than the total cycle time for regulatory readiness. Academic institutions continue to have predictable, elevated cycle times related to the LOA. Possible reasons include: Multiple departments at the institution that must review and approve components of the LOA, including the budget. Academic institutions tend to request higher overhead in the budget than community based investigators that are able to utilize the services of a central IRB. Many academic institutions will not approve/fully execute the LOA until AFTER final IRB approval has been issued. Keys to decreasing the cycle time for approval include: Master Clinical Trial Agreement will decrease the cycle time of the LOA due to prior approval of the legal language for the sponsor/institution. Ensure that the components for the clinical trial agreement (budget) are distributed to the correct departmental contact at the institution. Increased communication between for both the sponsor and site with the respective financial departments. This will ensure that the financial office is aware of the final IRB approval, preventing further delays related to the LOA.
  • Progressive and sustained cycle time reduction has been attributed to: Enhanced project management Identification of site regulatory readiness procedures Academic institutions are again predictable with regard to the time required to complete regulatory readiness processes. This can be due to consistent processes that must be followed based on the academic institution SOPs. Keys to reduction of cycle time for academic institutions include: Early identification of regulatory readiness procedures at the academic institution.
  • The regulatory readiness data for academic institutions on the control chart does seem to be in control. While there are 9 data points above the upper control limit, the majority of the cycle time data appears to be in control. Key to note on this control chart is that no data drops below the lower control limit. The data lies very close to the average of 182.9 days. Explanation for the low variability can be attributed to the standard requirements that needed at academic institutions regarding clinical trial implementation.
  • The data on this graph represents the percentage of trial sites at academic institutions that were able to complete the regulatory readiness procedures by the date of the planned first patient visit date of the trial. The data confirms that clinical trial timelines that have less than 140 days for the regulatory readiness phase will unlikely be successfully implemented at academic institutions alone. In order to enhance trial implementation and patient enrollment, a mix of academic and community based investigators, will be needed. Trial cycle times for regulatory readiness should ensure that appropriate time is available for academic institutions.
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    1. 1. CTSA Clinical Research Management Workshop Improving Clinical Trial Cycle Times through Increased Partnership Nancy Trapp Clinical Operations Team Leader-Regulatory Eli Lilly & Company
    2. 2. Current State <ul><li>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. </li></ul><ul><li>Eli Lilly and Company (Lilly) is currently performing at an average of approximately 125 days for academic sites becoming regulatory ready. </li></ul><ul><li>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. </li></ul>
    3. 3. Data on file at Eli Lilly and Company
    4. 4. Data on file at Eli Lilly and Company
    5. 5. Data on file at Eli Lilly and Company
    6. 6. Data on file at Eli Lilly and Company
    7. 7. Data on file at Eli Lilly and Company
    8. 8. Sponsor: Mike Amey JH/Chris Davis LLY Black Belt: Kathy Ann Lawrence Project #: 4279 Country: USA <ul><li>Problem </li></ul><ul><li>Multiple review boards and serial process steps lead to lengthy site readiness activities when partnering with academic research centers.   </li></ul><ul><li>Johns Hopkins/Lilly has median values for Site Readiness (CTRB shipped to CT ordered) at 169 days.  </li></ul><ul><li>Goal </li></ul><ul><li>Our goal is to reduce variability and cycle times within the site readiness process for Johns Hopkins research sites by 15% (24 days).  </li></ul><ul><li>Project Approach </li></ul><ul><li>Champions, sponsors, and team members from Johns Hopkins and Lilly. </li></ul><ul><li>Two-day face-to-face meetings in Measure, Analyze, and Improve in alternating facilities. </li></ul><ul><li>Openness and trust in the partnership to put it all on the table for discussion and improvement. </li></ul><ul><li>Internal communication within each partner and external via publication. </li></ul><ul><li>Root Causes </li></ul><ul><li>Lack of communication about where the study is in the process </li></ul><ul><li>Lots of wait time within and between steps </li></ul><ul><li>Unclear contact person at JH and/or Lilly </li></ul><ul><li>Solutions </li></ul><ul><li>Improved communication tools </li></ul><ul><li>Improve CRC process and tracking tools at JH </li></ul><ul><li>Help for the PI and JH staff </li></ul><ul><li>Expected Results </li></ul><ul><li>A 37% reduction in regulatory readiness cycle time (from a median of 169 days to 107 days). </li></ul><ul><li>Validation </li></ul><ul><li>Lilly to provide list of trials in Oncology and other therapeutic areas. </li></ul><ul><li>JH will also measure other sponsor improvements in Oncology. </li></ul>Johns Hopkins / Lilly – Oncology Improving Regulatory Readiness Timelines
    9. 9. Johns Hopkins / Lilly Six Sigma - Potential Root Causes for Delayed Cycle Times <ul><li>Lack of communication about where the study is in the process (both at the academic institution and sponsor) </li></ul><ul><li>Lots of wait time within and between steps </li></ul><ul><li>Unclear contact person academic site and/or sponsor </li></ul><ul><li>Lack of process definitions and lack of knowledge about process </li></ul><ul><li>Lack of access to information </li></ul><ul><li>Lots of hand-offs </li></ul>
    10. 10. Johns Hopkins / Lilly Six Sigma
    11. 11. Johns Hopkins / Lilly Six Sigma Tips and Tricks <ul><li>Establish single point of contact (sponsor and academic institution) </li></ul><ul><li>Understand each other’s processes and required internal reviews (process, timing, requirements) and expectations </li></ul><ul><li>Complete a Template / Master Letter of Confidentiality </li></ul><ul><li>Master Letter of Agreement </li></ul><ul><li>Standard template for non-protocol pieces of ICD and ‘usual’ procedure language </li></ul><ul><li>Site budget out of Lilly within 5 days and accompanied by protocol </li></ul><ul><li>Continued technological advancements and IT solutions </li></ul><ul><li>Consistent and frequent communications and status updates </li></ul>
    12. 12. Johns Hopkins / Lilly Six Sigma Improvements <ul><li>Improved Communication </li></ul><ul><li>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 </li></ul><ul><li>Partner JH with Lilly-Budget Office and Lilly-Contract Office to resolve template issues and overhead </li></ul><ul><li>Agreed on use of .pdf files and signatures in any order on study amendments to Master Service Agreement </li></ul><ul><li>Improve the CRC Process / Tracking System </li></ul><ul><li>Lilly – Investigator Portal – Goes live throughout 2008 </li></ul><ul><li>JH – CRMS – Goes live July 1, 2008 and will have many features including a dashboard </li></ul><ul><li>Help for the PI </li></ul><ul><li>Dashboard in CRMS </li></ul><ul><li>Standard Confidentiality Agreement </li></ul><ul><li>Standard Master Service Agreement </li></ul><ul><li>Standard Informed Consent </li></ul><ul><li>Standard costs for Pharmacy, SAC Lab, and Professional fees </li></ul>Green = Quick Win Blue = Improvement with Simulation Black = Future Benefit
    13. 13. Questions, Feedback, Concerns