UC Davis CTSC and UC Davis CTSC and VANCHCS CollaborationVANCHCS Collaboration

UC Davis CTSC and UC Davis CTSC and VANCHCS CollaborationVANCHCS Collaboration

Lars Berglund, M.D., Ph.D.Principal Investigator, UC Davis CTSC

Staff physician, VA Northern California HCSAssociate Dean for Research, UC Davis

Ted Wun, M.D.Chief, Hematology Oncology UC Davis SOM and

VANCHCSDirector, CRRF, UC Davis CTSC

OverviewOverview

• VA Northern California Health Care System

• UC Davis Health Care System

• Chronology of Affiliation to Integration

• Accomplishments

• Lessons Learned– Facilitators– Barriers

VANCHCS in the 1980’sVANCHCS in the 1980’sVANCHCS in the 1980’sVANCHCS in the 1980’s

• Large inpatient facility based in Martinez, CA• UC Davis affiliated, but not integrated training

programs• Separate research programs

– Oncology– Infectious Disease– Neurology– Rheumatology

UC Davis School of Medicine UC Davis School of Medicine 1980’s1980’s

UC Davis School of Medicine UC Davis School of Medicine 1980’s1980’s

• First class 1972 - Medical School focused on Primary Care and serving Central Valley

• Modest research portfolio• Clinical research minimal

• Decision in the early 1990’s to grow the research enterprise– However, no space allocated in new hospital

expansion for a GCRC facility

Stimulus to IntegrationStimulus to IntegrationStimulus to IntegrationStimulus to Integration

Loma Prieta Earthquake 1989

VA Medical Center Moved to SacramentoVA Medical Center Moved to SacramentoVA Medical Center Moved to SacramentoVA Medical Center Moved to Sacramento

8 miles

Allowed integration of Faculty and Housestaff

UC Davis/VA GCRCUC Davis/VA GCRCUC Davis/VA GCRCUC Davis/VA GCRC

• VA planners had wisely allocated clinical and wet-lab research space in new hospital plans– UC Davis planners had not allocated space for a

GCRC• Lars Berglund recruited to be PI – foundation for NIH

application developed 2002-2003• VA hospital completed and GCRC application submitted

2003• UC Davis/VANCHCS 2nd to last GCRC to be NIH funded

(Sept 2004)

Integration of Research?Integration of Research?Integration of Research?Integration of Research?• Unified clinical research facility but barriers

existed– Independent VA and UC Davis IRB’s

• UC Davis faculty predominantly unwilling to submit to two IRB’s given an increased regulatory burden and lack of harmonization

– Lack of critical mass of researchers– Lack of suitable IDS support

• But then a second stimulus arrived, NIH CTSA initiative– VA/UC Davis CTSC (2006)

Transformation of research Transformation of research infrastructure by the CTSC Integrationinfrastructure by the CTSC Integration

Transformation of research Transformation of research infrastructure by the CTSC Integrationinfrastructure by the CTSC Integration

Barriers RemovedBarriers RemovedBarriers RemovedBarriers Removed

• UC Davis/VA IRB MOU for oncology and neurology studies– Allowed for single consent and IRB committee– Moving towards full affiliation agreement

• Shared resources– VA Oncology nurses train UC Davis CTSC nurses in

chemotherapy – CTSC resource for infusion studies– VA Task order for UC Davis personnel– Agreement for use of VA clinical labs, nutrition, and ED services– Clinical Research Coordinators, Dietician, Physiologist– Dual VA/UC Davis investigators use CTSC resources (access to

pilot funding, training support)

Mutual BenefitMutual BenefitMutual BenefitMutual Benefit

• Significant increase in VA engaged research– Offer cutting edge research to VA patients

• Increased accrual to oncology trials for UC Davis NCI-designated cancer center

• Clinical research resources that would not otherwise be available for both

• Effectively leverage limited FTE• VA researchers participating in CTSC – trainees,

pilot funds, workshops

Results to dateResults to dateResults to dateResults to date

• All applications for CTSC use reviewed for VA engagement and appropriate use and cost recovery of VA resources

• Mutual committee participation (CTSC Advisory committee, R&D committee, Research Integration committee)

• Increase in CTSC VA engaged studies from 5 to 39

• Increased VA research funding to $32 M

Training and mentoringTraining and mentoringTraining and mentoringTraining and mentoring• VA-based trainees eligible to apply for CTSC training

programs • CTSC developed multiple education, training and

certification programs for research staff – VA staff participating

• Established residency research rotation – all residents in Internal Medicine complete month-long research rotation and develop study protocol

• Rotation expanded to other disciplines (Anesthesiology)

CTSC funding

Recipe for SuccessRecipe for SuccessRecipe for SuccessRecipe for Success

• Champions– Leadership, “middle management”, ground

troops

• Integration of leadership– Vested in both institutions

• Tenacity

• Understanding that it is win-win

Barriers Still ExistBarriers Still ExistBarriers Still ExistBarriers Still Exist

• There are still parochial interests

• Financial

• Need for clinical space

• But, willingness to discuss issues and ongoing efforts to resolve barriers

But all barriers eventually fallBut all barriers eventually fallBut all barriers eventually fallBut all barriers eventually fall