“Tennessee’s state-wide multi-site clinical trial facilitator – Hospital operated, academically supported, powered by a robust research enterprise data ware- house, for superior performance and increased sponsor engagement.”
The Clinical Trials Network of Tennessee (CTN2) has been activated. It will operate as a separate 501(c)(3) subsidiary of the University of Tennessee Research Foundation (UTRF), the non-profit 501(c)(3) organization whose mission is to promote the commercialization of UT intellectual property, en- courage an entrepreneurial culture, contribute to state and regional economic development and pro- mote research and education to benefit the people of Tennessee and beyond. CTN2 was created to enable the University of Tennessee Health Science Center (UTHSC) clinical research faculty to design, solicit, and conduct robust statewide clinical trials with the overarching goal of providing new therapeutics and medical devices aimed at improving the health of all Tennesseans.
The Clinical Trials Network of Tennessee was the vision of Steven R. Goodman, PhD, vice chancellor for Research at UTHSC. “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,” Dr. Goodman, who has been elected to serve as the interim president and CEO of CTN2, said.
Dr. Goodman and his CTN2 team presented the idea to create a 501(c)(3) organization as a wholly-owned subsidiary of the University of Tennessee Research Foundation to the UTRF Board of Directors on December 5, 2017 and it received unanimous approval. Having a separate clearinghouse for clinical trials at UT decreases administrative functions and permits a more streamlined budgeting and contracting process for this cross-institutional initiative. CTN2 will allow UTHSC faculty to respond to opportunities for clinical trials at the speed of industry. The UT Board of Trustees has agreed to provide $3 million in funding to UTRF to support CTN2’s first three years of operation.
Dr. Goodman enlisted several key players to help establish CTN2 including members of UTHSC and UTRF’s upper administration; Phil Cestaro, president and CEO of TriMetis Life Sciences and UTHSC’s new associate vice chancellor for Research and Business Development; Robert Davis, PhD, Governor’s Chair in the UTHSC-Oak Ridge National Laboratory Center in Biomedical Informatics and professor in the Department of Pediatrics; Ari VanderWalde, MD, MBioeth, associate vice chancellor for Clinical Research; and Karen Johnson, MD, MPH, Endowed Professor of Women’s Health in the Department of Preventive Medicine. Stacey Patterson, PhD, president of UTRF; Richard Magid, vice president of UTRF at UTHSC; and Bill Mason, JD, secretary and General Counsel for UTRF were all key consultants in the development of CTN2.
The university’s partner hospitals include Methodist University Hospital, Le Bonheur Children’s Hospital, Regional One Health, West Cancer Center, Saint Thomas Health in Nashville, the University of Tennessee Medical Center in Knoxville, and Erlanger Health System in Chattanooga. CTN2 has incentivized buy-in from these partner hospitals by providing its services without charge, including their representatives on the CTN2 Board of Directors, and providing personnel to support clinical trials at the hospitals.
“Based on UTRF’s experiences supporting other projects across UT, we’ve established CTN2 as a nonprofit UTRF subsidiary and set up the bylaws to ensure that its governing Board represents all of the stakeholders,” Dr. Magid, who has also been elect- ed to serve as the UTRF board representative for CTN2, said.
INTEGRATING BIOMEDICAL INFORMATICS
Intricately linked to CTN2 is the development of a HIPAA-compliant Enterprise Data Warehouse (EDW) for all CTN2 partnering medical center patients. The network platform that UTHSC and CTN2 will use belongs to TriNetX, a global provider with data on nearly 100 million patients in over 10 countries, whose state-of-the-art security and privacy procedures, including HIPAA compliance, have been verified by independent experts specialized in big health data analytics and infrastructure.
Dr. Robert Davis serves as the lead curator for the research Enterprise Data Warehouse and said work on the EDW and the biorepository is already underway.
“It’s very difficult to get enough sample subjects from one health center for a good clinical trial,” Dr. Davis said. “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.”
SUPPORTING THE INFRASTRUCTURE
In addition to the Enterprise Data Warehouse, CTN2 will provide clinical trials budgeting and contracting, site management, site quality assurance, sponsor relationship management, central IRB management, and other resources. Phil Cestaro will serve as CTN2’s executive director responsible for the overall leadership of CTN2, including but not limited, to overseeing the budget, services provided, procurement of new clinical trial projects, and other activities as 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 streamlined start up and contracting processes,” Cestaro said. “CTN2’s unique combination of centralized business resources, incorporation of an EDW, and the resources available through the UT Board of Trustees differentiate it from other clinical trials programs.”
Additionally, CTN2 will have Dr. VanderWalde serve as its Medical Director. As the Medical Director, Dr.VanderWalde understands the clinical aspects of the research protocol and has the ability to have discussions with study sponsors on the pros and cons of different protocols and pipeline activities.
THE CLINICAL TRIALS GOVERNANCE BOARD
The UTHSC Clinical Trials Governance Board (CTGB), the university’s fully integrated Federated Model for developing and sharing best practices for clinical research through institution-wide offerings, has also been created by Vice Chancellor for Research Goodman. Heading the CTGB are Drs. VanderWalde and Johnson. UTHSC Chancellor Steve Schwab, MD, has provided a $3 million “boots- on-the-ground budget” to the CTGB so that it will be able to successfully provide the necessary clinical trials staff needed to support the level of clinical trials CTN2 will attract.
“Currently, there are a number of clinical research offices that exist at UTHSC each with specific expertise, focus, and infrastructure,” Dr. VanderWalde said. “Through the CTGB we are beginning to integrate these offices and share best practices across Clinical Research Offices as well as encourage a staffing model that takes advantage of resources across groups.”
Dr. Johnson adds that the CTGB aims to facilitate clinical research and promote collaborations within and across departments, colleges, and campuses as well as within the UT System and beyond. Dr. Johnson has been designated to lead the UTHSC effort as it works to become a Clinical and Translational Science Award (CTSA) site.
“CTN2, CTGB, and the Enterprise Data Warehouse will be central to our ability to obtain a CTSA designation,” Dr. Johnson said.
With the Clinical Trials Governance Board already working to better support clinical research faculty, and the successful creation of The Clinical Trials Network of Tennessee and the Enterprise Data Warehouse, Dr. Goodman’s vision to enhance clinical research activity is becoming a reality. UTHSC is positioning itself “to contest for competitive grants and contracts and attract and retain outstanding faculty members with the ultimate goal of stimulations research initiatives and growing its research footprint,” Dr. Goodman said.
Chancellor Schwab echoes Dr. Goodman’s excitement. “CTN2 will accelerate our faculty’s ability to conduct patient-based investigation,” Chancellor Schwab said. “This final step in the bench-to-bedside pathway of improving patient care through new medicines and new techniques is essential to bringing health care advances to the people of Tennessee.”
CTN2 Memorandums of understandings and articulation agreements are being signed with each partner hospital location. Dr. Goodman anticipates CTN2 will be accepting clinical trials by May or June 2018.