Clinical Trials Network Advancing Health Care for Tennesseans

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Just one year since its inception, the Clinical Trials Network of Tennessee (CTN2) has secured contracts to work with nine clinical sites across the state and has enrolled over 20 Tennesseans as patients in their trials. The innovative clinical trials network aims to provide new therapeutics and medical devices with the overarching goal of improving the health of all Tennesseans.

Operating as a separate 501(c)(3) subsidiary of the University of Tennessee Research Foundation (UTRF), CTN2 is a state-wide, multisite clinical trial facilitator designed to bring together hospitals, academic-grade research, and shared health data from across Tennessee. CTN2 enables clinical research faculty of the University of Tennessee Health Science Center (UTHSC) to design, solicit, and conduct robust statewide clinical trials with the support of a superior research enterprise.

“This network meets a huge need for UTHSC clinical research,” said Steven R. Goodman, PhD, vice chancellor for Research at UTHSC and president and CEO of CTN2. “UTHSC is a leader in health care innovation and health technology, and CTN2 takes patient care to the next level by opening up access to novel therapies and medical devices.”

Launched in April 2018, CTN2 has numerous studies underway and in its pipeline. Three clinical trials have been contracted, two of which are open and actively enrolling patients: a phase II trial in colon cancer and another building an outcomes registry for heart transplants. More than 10 therapeutic studies are preparing to launch: phase I trials in advanced malignancies and oral premalignant lesions; phase II trials in heart failure; and phase III trials in bladder cancer, heart failure, and cardiomyopathy. A separate phase III study is forthcoming in ophthalmology.

CTN2 is also spearheading research and data mining projects into the procurement of human biospecimens and post-market surveillance for medical device implants.

The novel clinical trials network is a unique asset to Tennessee residents, and as CTN2 grows, it will be a boon to public health and health care access. With affiliated practices and hospitals across the state, citizens in every region now have the opportunity to participate in CTN2 studies and reap the benefits of clinical research. Tennesseans have historically been underrepresented in large-scale studies leading to drug approval. In addition, CTN2 affords state residents potential access to effective medications prior to wide approval.

“All Tennesseans stand to benefit from CTN2’s success, particularly the partnerships it’s building between hospitals, academia, and partners from the pharmaceutical and medical device industries,” said Richard Magid, vice president of UTRF. “Just one year in, CTN2 is already bringing novel medical studies home to state residents who need them, right here in their own communities.”

Dr. Goodman and his team presented the idea to create CTN2 on December 5, 2017, and it received unanimous approval. Having a separate clearinghouse for clinical trials because of CTN2’s creation decreases administrative functions and permits a more streamlined budgeting and contracting process for this cross-institutional initiative. CTN2 allows UTHSC faculty to respond to opportunities for clinical trials at the speed of industry.

A series of operational benchmarks to which future CTN2 funding would be tied were outlined by UTRF and the University of Tennessee in April 2018. CTN2 met or exceeded all 2019 fiscal year objectives, prompting the UTRF Board of Directors to recently endorse the release of 2020 funding to CTN2.
With numerous clinical trials underway and more in the pipeline, CTN2’s success is expected to continue advancing patient-based research at UTHSC with the ultimate goal of bringing new techniques and medicines to the citizens of Tennessee.