With a new nonprofit subsidiary, the University of Tennessee Health Science Center will rival private industry.
The University of Tennessee Health Science Center (UTHSC) launched the Clinical Trials Network of Tennessee (CTN2), a separate nonprofit to its research foundation, so its faculty can design, solicit and conduct statewide clinical trials as quickly as the private sector.
“CTN2 will provide robust statewide clinical trials that will improve medical treatments while providing UTHSC credit for the clinical trial contracts being performed by its faculty who are located at participating hospitals throughout the state,” said Dr. Steven R. Goodman, vice chancellor for research at UTHSC, who envisioned the program.
The subsidiary will decrease administrative functions and create a more streamlined budgeting and contracting process for cross-institutional clinical trials. In other words, CTN2 will allow the school’s faculty to respond to opportunities for clinical trials “at the speed of industry,” UTHSC said in a news release.
The effort is similar to the University of Memphis’ separate, for-profit company — UMRF Ventures — which was created last year and enabled the university to bid on outsourced contracts, such as IT services, like any other third-party company.
UTHSC is also developing a HIPAA-compliant Enterprise Data Warehouse (EDW) to store all patient data for CTN2-partnering medical centers.
“It’s very difficult to get enough sample subjects from one health center for a good clinical trial,” said Dr. Robert Davis, lead data warehouse curator. “Through the EDW, UT researchers will have access to more patient data than ever before, allowing for project collaboration and the development of products and solutions for patients and our community, no matter their physical location.”
In addition to the data warehouse, CTN2 will provide budgeting and be contracting for clinical trials as well as site management, quality assurance, sponsor-relationship management and other resources similar to the private sector.
CTN2 will be led by executive director Phil Cestaro, also president and CEO of TriMetis Life Sciences and UTHSC’s new associate vice chancellor for Research and Business Development. Cestaro will oversee the budget, provided services, procurement of new clinical trials and other activities assigned by the CTN2 board of directors.
“CTN2 will provide pharmaceutical and medical device companies access to the talent in academia and a diverse patient population throughout the state of Tennessee via a streamlined start-up and contracting processes,” Cestaro said.
In November, the UT Board of Trustees committed $3 million to support the first three years of CTN2. On March 23, the board agreed to release the funds for the first year.
Memorandums of understanding and articulation agreements are expected to be signed by each partner hospital location. Leadership expects CTN2 to begin accepting clinical trials by May 2018.