1. RECOGNITION OF CLINICAL TRIAL CANCER RESEARCH
March 30, 2015
Cancer Center Administrator’s Forum
Lexington, KY
Frederick R. Ueland, MD
Professor and Director
Division of Gynecologic Oncology
University of Kentucky

2. Background
UK HealthCare leadership understand importance of clinical trial research, are highly supportive and providing funding
Challenge: Design a new system to promote clinical trial participation
Aligned and equitable
Incentivize physicians without direct payments
Standardize ‘Distribution of Effort’ for clinical faculty using the EPAT system (Effort and Productivity Assessment Tool)
Non-sponsored Research
EPAT compares clinical productivity (RVUs) to national norms. Based on traditional “academic” metrics: teaching, service and research

3. 14-Nov-18

4. Accrual History at Markey Cancer Center
EPAT system adopted
Dr. Evers hired
NCI-designation

5. Estimated Accrual- Future Goals

6. Developing a Novel System to Promote Clinical Trial Research
Establish a clinical research fund (CRF) & CRF Oversight Board
Define target activities, method of recognition, quantitate value, assemble variables
Integrate MCC membership rules for clinical research; regular audits of model
Analysis of the current faculty title series structure and recommend changes to the Dean
Increased Clinical and Translational Research Effort

7. Recognizing Research Effort
Define incentive-based model that recognized effort for clinical trial research and aligned the MCC research mission with UK HealthCare strategic goals
What to value?
10% for design and management of investigator-initiated trials (IIT)
10% for trial management including adverse events and regulatory work
80% for patient enrollment

8. Clinical Research Enrollment and Development of Investigational Trials (CREDIT)
Name CREDIT Board
Establish bylaws, define scope of recognized activities, relative values, and method of measurement
Quarterly meetings
Review metrics, calculate effort, and recommend % effort for non-sponsored research to Department Chair and Dean
Determine minimum participation (3-5 accruals per year)
Determine an equitable way to encourage new faculty participation (1 year baseline percentage)
Determine an audit process to monitor fairness and effectiveness

9. Proposed MCC CREDIT Board
Board Members
Director of Markey Cancer Center (Chair)
Director for Administration and Finance
Director of Operations of MCC CRO
Associate Director for Clinical Translation
Division Chief of Gynecologic Oncology
Faculty, Department of Radiation Medicine
Faculty, Division of Hematology and BMT
Faculty, Department of Pediatrics (Hem/Onc)
Non-voting
Database Analyst and OnCore Design Specialist
Ad Hoc Membership
Determined by MCC CREDIT Board

10. Cost of the CREDIT Plan Non-sponsored research
Departments (COM) support non-sponsored research for faculty involved in clinical research
$400,939 for FY2013
The initial annual estimated cost of CREDIT
$800,000-$1,000,000
Differential cost guaranteed by UK HealthCare enterprise
Aggregate funding includes COM and MCC (via EVPH transfer)

11. Quantifying the Metrics
General Considerations
Therapeutic trials only
Standard trials
‘Complex’ trials are phase I, complicated phase II, other
CREDIT Board verified
Investigator-Initiated trials (IIT)
Industry-sponsored
No PI effort recognized for industry-sponsored trials since PI funding already allocated in study budget

12. Quantifying the Metrics
Principal Investigator for non-IIT
Up to 1% effort (0.01 FTE) annually
0.01 x (1/365) per day from first accrual to closure
0.25% effort per accrual to 1% (0.01 FTE) during the first 12 months
Awarded once
Principal Investigator for IIT
Up to 4% (0.04 FTE) annually
0.04 x (1/365) per day from first accrual to closure
Accrual
0.5% effort (0.005 FTE) per patient for standard trials
1% effort (0.01 FTE) per patient for complex trials

13. Quantifying the Metrics
4. New Members
Receive % effort based on rank and experience
quarterly review and adjustment to reflect activity
First 12 months
Assistant Professor 5% effort (0.05 FTE)
Associate/Full Prof 10% effort (0.10 FTE)
Other Individual review by CREDIT Board
5. Cap
Faculty Research Effort capped at a maximum effort of 33% (0.33 FTE)
Review by CREDIT Board at 12 months

14. 14-Nov-18

15. Timeline October 2014- CREDIT system implemented
MCC CREDIT Board quarterly review
Every 2Q- faculty effort calculated by MCC CREDIT Board and forwarded to administrators
Annual- adjustments unless >20% variance in CREDIT total for two consecutive quarters
April first 2Q reviewed
July CREDIT plan fully implemented in fiscal year budget

16. Lessons Learned Obtain support from COM Dean and Department chairs
Create faculty awareness with open communication
Accrual lags behind implementation
Enrollment shows moderate variability by quarter
Exclude industry-sponsored PI effort to avoid dual credit
Leadership must value clinical trial research and agree ongoing financial support