I. What is CTN2?
CTN2 is the Clinical Trials Network of Tennessee. With CTN2, UT faculty and collaborating investigators and institutions can design, solicit, and conduct clinical trials of high integrity across campuses and institutions in Tennessee.
II. Why did we create CTN2?
To enable UT faculty and collaborating researchers to design, solicit, and conduct robust statewide clinical trials in order to increase access to new therapies for patient care, research opportunities and education, and also to enable UTHSC to get credit for clinical trials conducted by its faculty. CTN2 encourages buy-in of Tennessee research hospitals by including their representatives on the CTN2 board. CTN2 is not intended to earn profit, but will attempt to recoup costs to ensure opportunities for growth and further outreach.
III. What type of organization is CTN2?
CTN2 is a Site Management Organization (SMO). A Site Management Organization (SMO) is an organization that aggregates a number of different health care providers/clinics o provide clinical trial related services to sponsors looking to have access to multiple sites to conduct a clinical trial.
IV. What types of clinical trials will we be accepting?
CTN2 will support all types of clinical trials, with focus on trials with a financial sponsor such as pharmaceutical and medical device companies. Individual researchers, research consortia, or governmental organizations also use SMOs to conduct clinical trials.
V. Why not do this under University of Tennessee versus a separate 501c3?
Having a separate clearing house for clinical trials relieves UT of these administrative functions and permits a more streamlined contracting process for this cross institutional initiative while allowing UT faculty to respond to opportunities for clinical trials at the speed of industry. As a UTRF subsidiary, CTN2 research expenditures are credited to UT, and UTHSC and UTRF will have representatives on the CTN2 board.
VI. Is my data safe? How do I know my data will remain safe?
CTN2 will contract with UTHSC to use UT IT resources to operate and secure the enterprise data warehouse (EDW) of patient data (see description below). The network platform that UTHSC and CTN2 will use belongs to TriNetX, a global provider with nearly 100 million patients in over 80 healthcare organizations, whose state-of the-art security and privacy procedures, including HIPAA compliance, have been verified by independent experts including Dr. Brad Malin from Vanderbilt. In addition, each participating hospital will have a representative on the CTN2 Board to participate in CTN2 governance and to maintain transparency.
VII. What is an EDW?
The EDW is simply a standardized approach to cataloging and organizing data. It can be comprised of data from different EMRs (Cerner, Epic, etc) and includes other data as well (radiology; pathology; text; genomics). EDW's are now essential to participate in many federal initiatives (such as the CTSA program) but their data can also be used locally for population health management or for clinical improvement efforts.
VIII. What are the components of CTN2?
The components of CTN2 include: enterprise data warehousing, clinical trial budgeting and contracting, site management, site quality assurance, sponsor relationship management, central IRB management, etc.
IX. Will CTN2 utilize UT employees to deliver on services outlined in the Business Plan?
CTN2 will operate as an independent organization and utilize its own employees. Where it is more efficient or practical, UT employees may be assigned to CTN2 or may be consulted and collaborated with as a research partner with CTN2.
X. Will CTN2 rely on UTRF for funding or support?
CTN2 funding is being provided by UTHSC as authorized by the UT Board of Trustees for 3 years, based on the annual achievement of milestones. CTN2 is not looking for UTRF funding, although CTN2 does plan to contract with UTRF for certain finance, HR and other services, at CTN2's expense, where that is efficient and practical.
XI. How will we measure CTN2 success?
Our metrics for success are:
i. Aggregating and increasing the number and quality of clinical trials that are conducted across UT sites
ii. Advancing medicine and patient care through cutting edge research
iii. Increased numbers of trials, number of patients enrolled in trials, and number of subject visits
XII. How are clinical trial agreements measured financially?
Clinical trial grants are measured financially in 2 ways:
i. Total Contracted Value - Total Contracted Value is the possible revenue that can be earned if all of the patients contracted are accrued by the research site to the trial.
ii. Revenue Earned - Revenue earned on a clinical trial is typically less than the Total Contracted Value.
XIII. Will there be SOP’s for CTN2 and SOP’s for Site?
No. CTN2 and Site will align their SOP’s. Each Site’s SOP’s will be followed.
XIV. How are contracts managed for each Site?
Each Site has a Master Clinical Trial Agreement (MCTA) with CTN2 that provides Site’s acceptable language. CTN2 reviews language in Sponsor’s Clinical Trial Agreement and compares with the Site/CTN2 MCTA, working with the Site in its review and approval and to identify areas of negotiations. CTN2 facilitates the negotiations between Sponsor and Site.
XV. How are Budgets managed for each Site?
Each Site is responsible for conducting its own budget and cost analysis for research fees according to fair market. CTN2 reviews the Site’s edits and facilitates budget negotiations between Sponsor and Site.
XVI. How are payments managed for each Site?
All Site payments from Sponsor will be issued to CTN2. CTN2 will administer and track all payments to individual Sites.
XVII. How will regulatory submissions be managed?
In accordance with the Site/CTN2 SOP, CTN2 submits to the Sponsor-designated Central IRB on Site’s behalf. Sites who are required to use a local IRB will submit on its own behalf.
XVIII. How does a Sponsor/CRO connect with CTN2 to find Sites for their trials?
CTN2 receives Study opportunities from various sources to include existing relationships with pharmaceutical and medical device companies and through TriNetX, a third party remote access to a state-wide Tennessee Enterprise Data Warehouse. CTN2 works with its PI Champions within each Disease Group to assess interest and feasibility. CTN2 executes the Confidentiality Agreement.