Who We Are
Principal investigators engaged in clinical research are challenged by competing needs. PIs must recruit and create the best studies available, and at the same time ensure rapid start-up and profitability of trials. Academic affiliation and university participation are the best ways to ensure the former, while individual institutions have historically been more accomplished in expediting study start-up and profitability. The Clinical Trials Network of Tennessee (CTN2) is a 501(c)(3) subsidiary of UT Research Foundation (UTRF), governed by a Board representing participating hospitals (including hospital systems and large practice plans), to enhance state-wide multi-site clinical trials involving the University of Tennessee Health Science Center (UTHSC) faculty, participating hospitals and our practice plans. The creation of an integrated CTN2 resource will leverage the best of both worlds - it will provide university based credibility and recruitment opportunities while employing expert contract capabilities geared to enabling rapid, hospital - led study start-up - to supplement rather than compete with current institutional resources, thereby engaging more sponsors for more trials.
Contract and Billing; Using the CTN2 framework, additional expertise in Contract and Billing beyond that currently available within most participating hospitals will be provided for participating studies. With dedicated expertise and management systems in solicitation response, rapid drafting and execution of contracts, participating hospitals will be free to use these resources in conjunction with their grants office to streamline and expedite processes.
Institutional Review Board; To promptly obtain all require human-subject approvals for multi-site Clinical Trials, CTN2 will facilitate regulatory review per local and institutional regulations, consistent with the preferences of PIs, participating hospitals, and funding sources via an appropriate Internal Review Board.
Intellectual Property; As a subsidiary of UTRF, CTN2 will be able to arrange for PIs and participating hospitals access to UTRF's established Intellectual Property protection and commercialization process, staff expertise, marketing reach, and assistance in bringing intellectual property from "concept to market".
Enterprise Data Warehouse (TN-EDW)
A statewide Tennessee Enterprise Data Warehouse (TN-EDW) will provide data resources for CTN2. Developed by UTHSC, TN-EDW will encompass: (1) Data from each participating hospital will be extracted and placed into a common data model (CDM). The CDM will ensure data from each participating hospital is consistently aligned and represented, compatible with large network formats sush as OHDSI-OMOP, Sentinel Initiative or PCORNET; (2) Data from each participating hospital will be derived from all its contributing EMRs. For example, data will be extracted from Cerner, Epic, Allscripts, eClinical, OncoEMR, or other vendors, shared with TN-EDW and then transformed into a CDW format. This data will mature over successive iterations to include not only all structured data but also unstructured data (free text), image data, and genomic/omic data; (3) A de-identifiable version of TN-EDW will be available for preparatory-to-research type queries. Examination of the de-identified data for such prep-to-research queries will be accessible by UT investigators via visualization processes such as Tableau, i2b2, PRD (Pediatric Research Datamart, or similar; (4) Remote access to TN-EDW to thrid parties, such as TriNetX, will be established for the purpose of generating simple data counts (to assess, for example, numbers of eligible patients for a clinical trial) after necessary business arrangements have been signed off on by all parties.
CTN2 will be a 501(c)(3) Tennessee non-profit corporation, organized as a subsidiary of UTRF, the sole corporate member. We will be governed by a Board of Directors comprised of: (1) A representative from each participating hospital, nominated by the hospital and elected by UTRF (2) The UTHSC Chancellor or his/her designee (ex officio) (3) The UTRF President or his/her designee, (ex officio) (4) A qualified expert nominated by the UTHSC Chancellor and appointed by UTRF. For efficiency and economy, some overlap with UTRF officers, including UTRF Vice President, Secretary, and General Counsel, will occur. UTRF reserves approval of amendments to Charters or Bylaws.
CTN2 markets its network of participating hospitals and practice groups, and access to TN-EDW and statewide trial patients to clinical trial sponsor.
Clinical trial sponsors enter into contracts with CTN2 the terms of which flow down to participating hospitals that perform the clinical trials, designating its own Site Directors, employing the clinical trial coordinator, enlisting practice plans, seeing patients, collecting and reporting clinical trial data, all in the same manner as is now done by hospitals on an individual basis. Participating hospitals retain the same profit potential/risk of loss as when contracting directly with the clinical trial sponsor. CTN2 is not a risk-taking, or a profit-making, entity. Participant Hospitals contract with practice plans for physicians to care for patients in the trial, and collect and report clinical trial data, though their Site Directors, in accordance with trial protocols, in the same manner as is now done by hospitals on an individual basis. Clinical trial sponsor funding flows through CTN2 to participating hospitals and down to practice plans, as is now done. CTN2 will charge the sponsor a small administrative fee, as established by the Board, to cover a portion of marketing and contracting cost.
Benefits of Participating
All CTN2 participating hospitals will be able to participate in state-wide clinical trials negotiated by this 501(c)(3), at no additional cost, under the control of their Site Director, and without change in existing local trial coordination, practice, profitability and procedure. Trials could involve one, multiple or all participating hospital sites. Participating hospitals will have access to one-stop shopping with CTN2 providing contracting, billing and IRB services. TN-EDW data on potential clinical trial participants will allow clinical trial sponsors efficient assessment of and access to multiple Tennessee participating hospitals and clinical care networks. CTN2 offers trial participation on a non-exclusive basis; participating hospitals remain free to contract directly with sponsors when that is deemed advantageous. Economics of scale made available by the participation of Tennessee's leading clinical research hospitals, and CTN2's facility in contracting, is expected to attract more sponsors and more trials. Each participating hospital will have a seat on the CTN2 Board. Additionally, CTN2 will allow for the highest level of individual PI and participating hospital control over research activities. Board-specific approval of particular projects will be required only for studies that require resources beyond those provided by external funding. This allows for continued strategic control of projects by PIs and each participating hospital. UTHSC benefits for this arrangement also. As a University component, UTRF and its subsidiaries' research expenditures are included in UT's annual NSF HERD Survey response. This structure allows UT to account for research expenditures related to trials, improving UT's ranking and reputation and making participating hospitals, practice plans and medical school more attractive in recruiting and retaining research professionals and trial sponsors. In addition, increasing the sources of data to include a network of participating hospitals further enriches TN-EDW as an academic research tool. Hospitals interested in participating will be asked to designate a point of contact and sign a non-binding memorandum of understanding incorporating these conceptual terms as a basis for CTN2's official organization as a Tennessee public benefit corporation and a 501(c)(3) tax exempt entity.
In order to sustain a successful, state-wide multi-site clinical trial network, each participating hospital will appoint a Site Director. While executive level communications will be maintained through Board representatives, CTN2 will routinely work with each participating hospital's Site Director as the lead on conduct of clinical trials. The Site Director will also be regularly consulted on potential and pending clinical trials in the pipeline. The Site Director will be the main contact for the TN-EDW data transfer facilitation, and inevitably a key person in the hospital on deploying TN-EDW as a tool for researchers.