Transcript Slide 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
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
21-Jul-15
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Accrual History at Markey Cancer Center
300
EPAT system adopted
Dr. Evers hired
NCI-designation
250
200
150
100
50
0
2009
2010
2011
2012
2013
Estimated Accrual- Future Goals
4000
3500
3000
2500
Accrual
2000
New patients
1500
1000
500
0
2014
2015
2016
2017
2018
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
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 investigatorinitiated trials (IIT)
– 10% for trial management including adverse events
and regulatory work
– 80% for patient enrollment
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
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
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)
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
Quantifying the Metrics
1. 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
2. Principal Investigator for IIT
• Up to 4% (0.04 FTE) annually
– 0.04 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
3. Accrual
• 0.5% effort (0.005 FTE) per patient for standard trials
• 1% effort (0.01 FTE) per patient for complex trials
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
– Associate/Full Prof
– Other
5% effort (0.05 FTE)
10% effort (0.10 FTE)
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
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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 2015- first 2Q reviewed
• July 2015- CREDIT plan fully implemented in fiscal year
budget
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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
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