“And I’ll tell it and think it and speak it and breathe it. And reflect it from the mountain so all souls can see it” -Bob Dylan, A Hard Rain’s Gonna Fall
I came to UTHSC to find several clinical trial offices: Office of Clinical Research, Clinical Research Center, Office of Preventive Medicine Clinical Research, Pediatric Clinical Research Unity, Dental Clinical Research Center, Nephrology Clinical Outcomes and Clinical Trials Program, and Clinical Trials Offices on our Knoxville, Chattanooga, and Nashville campuses. They were functioning independently, but with little communication or collaboration. I created the Clinical Trials Governance Board (CTGB) as a federated model with representation from each Clinical Trials Unit. Dr. Ari VanderWalde was appointed as Chair, and Dr. Karen Johnson as Vice-Chair, and now the Clinical Trial Offices are working together collaboratively to create a robust environment for all types of clinical trials.
I arrived at UTHSC with the intent of creating a statewide clinical trials network, as I had done as part of SUNY REACH. It was more complex as SUNY owned their hospitals while UTHSC did not, but supplies the clinical faculty. I met Dr. Bob Davis who was hard at work on an Enterprise Data Warehouse (EDW). I shared the concept of a state-wide clinical trials network with an expanded EDW covering our partner hospitals at all locations. Bob was onboard, and we were off and running. Chancellor Steve Schwab and Executive Vice Chancellor Ken Brown came to me independently asking me to think about an old problem at UTHSC: getting credit for clinical trials conducted by UTHSC faculty at hospital sites that we did not own. As these clinical trial contracts were being executed outside of UTHSC we were not getting any annual credit, thus hurting our standing when we were compared to other academic health centers. The problem was challenging, but discussions with Dr. Stacey Patterson (now UT Vice President for Research and UTRF President) led to a solution. By creating the Clinical Trials Network of Tennessee (CTN2) as a 501(c)(3) wholly-owned subsidiary of UTRF, any clinical trial contract money that passed through this non-profit, even though it all ended up at the hospital sites where our UTHSC faculty were conducting the trials, would be accounted for via the HERD survey as part of UTHSC’s annual grants and contracts reporting. This leads to UTHSC rising in the annual rankings and the ripple effects that occur with a higher level of prestige. The UT Board of Trustees supported the concept with $3 million, over three years, given to UTRF which then transfers the money annually to CTN2. Meanwhile, Chancellor Steve Schwab understanding that the large number of statewide clinical trials would require a clinical trial “boots on the ground” workforce, supplied $3 million over three years to the CTGB to hire the necessary staff. We will be running clinical trials through CTN2 beginning in May or June 2018. Phil Cestaro is the CTN2 executive director, Dr. Ari VanderWalde the medical director, Bill Mason, Esq., is the legal counsel and I will be the interim president and CEO. All have played important roles in CTN2 development.
When I joined UTHSC, a CTSA application was being prepared that received a reasonable score but was not funded. I provided the UTHSC Research Council an alternative approach which they approved unanimously. The idea was to create a Delta Consortium CTSA application focused on our common patient demographics. We now have a Delta Consortium CTSA group composed of UTHSC, University of Mississippi Medical Center and Tulane Medical Center. This will be a multi-PI application with Drs. Karen Johnson and Michelle Martin being the PIs representing UTHSC. The focus of the grant will be health disparities. The application will involve all six UTHSC Colleges, all four campuses, CTN2, and the EDW. Karen and Michelle will be assisted by the CTGB, and many others, in the writing of the application.
I have now explained the integrated vision for future clinical trial research at UTHSC involving the 3Cs (CTGB, CTN2 and CTSA) plus the EDW. I predict that based on this vision and the dedicated leaders that are involved, we will experience a hard rain and “I’m a-go-in’ back out ‘fore the rain starts a-fallin’ . . . But I’ll know my song well before I start singin” – Bob Dylan, Nobel Laureate in Literature
-Steven R. Goodman, PhD Vice Chancellor for Research