1. LAPS Grant Update Anthony Elias, MD PI 2/12/15

2. Background of Grant Much of SOC determined by NCTN trials Reconfiguring of NCTN by NCI due to declining budgets 30 LAPS institutions funded by NCI U10 – NCI considers LAPS to be the mark of an elite institution – LAPS institutions will get priority for phase II contract Had to restructure elements of main member and affiliates Included UCH, PVHS, and MHS as clinical sites of the main member

3. LAPS/Cooperative Group Trial Activations

4. Cause of Delays in Protocol Activation 3/1/14-6/30/14: activating CIRB; consent boilerplate approvals RSS: evolving and increasing regulations and requirements; opaqueness Care plan construction in EPIC Baton passing: a myriad of steps; not uniformly identified Insufficient integration within UCHS – Hospital reviews – Pharmacy – Eventually G&C (not a significant barrier for NCTN trials)

5. Consequences Data

6. Monthly NCTN Accrual

7. LAPS/NCTN Accrual Goals

8. NCTN Accrual

9. Why UCHS and not just UCH? Successes Development of processes across system Greater knowledge of the people across the system – everyone is trying hard Uniform pricing structure CIRB Common EMR Development of faculty/community disease committees Enhanced patient referrals in both directions

10. Why UCHS and not just UCH? Threats Deadly slow activation of trials Processes so bogged down that each protocol handled individually Increased frustration of North and South with Central Devastation to accrual (68% of prior years) Few protocols – worst record of the 30 LAPS institutions Tremendous toll on CCTO financially Loss of accruals leads to loss of authorship and leadership LAPS grant cut for year 2 Jeopardizes ability to get phase II grant Have not fundamentally worked out institutional agreements between UC and UCHS – Bypass of University by retaining IRB and trial organization within UCHS Cannot yet proceed with pharma trials

11. Why UCHS and not just UCH? Solutions Common goals Increase patient access to clinical trials across system Increase accrual to clinical trials Integrate clinical research with clinical care These lead to BETTER PATIENT CARE We are all on the same side – ONE TEAM Need integration of pharmacies Need full system-wide buyin with trust Would be great for the University/SOM to have the same relationship with UCHS as is developing with UCH

12. Thank you

13. NCTN Accrual by Disease

14. NCTN Accrual 55 36 ACRIN 4 NRG SWOG

15. NCTN Accrual

16. NCTN Accrual Anticipated