FUNCTIONS & BENEFITS
Benefits of Participating
All CTN2 participating institutions may elect to participate in state-wide clinical trials negotiated by this 501(c)(3), at no additional cost to the site, 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 institution sites. Participating institutions have access to one-stop shopping with CTN2 providing contracting, billing, and central IRB services. TN-EDW data on potential clinical trial participants allows clinical trial sponsors efficient assessment of and access to multiple Tennessee participating institutions and clinical care networks.
Participating Institutions
CTN2 offers trial participation on a nonexclusive basis; participating institutions have final say in whether or not they conduct a study. Economies of scale made available by the participation of Tennessee’s leading clinical research institutions, the reputation of PIs, expertise and benefits of CTN2 Expert Boards, initial positive experiences of sponsors, investigators and participating institutions, and CTN2’s facility in contracting, promptly and reasonably, attracts more sponsors and more trials.
Each participating institution has a seat on the CTN2 board. Additionally, CTN2 allows for PI and participating institution control over research activities. Board specific approval of particular projects is 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.
University
UTHSC benefits from this arrangement. As a university component, UTRF’s 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, 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.
TENNESSEE ENTERPRISE DATA WAREHOUSE (TN-EDW)
A state-wide Tennessee research Enterprise Data Warehouse (TN-EDW) provides data resources. Secured behind the UTHSC firewall, TN-EDW encompasses:
Data from electing, participating institution extracted to a common data model (CDM). The CDM ensures that data from each institution is consistently aligned and represented, compatible with large network formats such as OHDSI-OMOP, Sentinel Initiative or PCORNET;
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Data from each participating institution derived from all its contributing EMRs. For example, data is extracted from Cerner, Epic, Allscripts, eClinical, OncoEMR, or other vendors. This data matures over successive iterations to include not only all structured data but also unstructured data (free text), image data, and genomic/omic data;
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A de-identifiable version available for preparatory-to-research type queries. The de-identified data for such prep-to-research queries is accessible by UT investigators via visualization processes such as Tableau, i2b2, PRD (Pediatric Research Datamart), or similar; and
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Remote access to de-identified data in the TN-EDW by third parties, such as TriNetX, 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 by all parties.
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Contracting & Billing
Using the CTN2 framework, additional expertise in contracting and billing beyond that currently available within some participating institutions is provided for CTN2- initiated studies. With dedicated expertise and management systems in solicitation response, rapid drafting and execution of contracts, participating institutions are free to use these resources in conjunction with their grants office to streamline and expedite processes, while continuing to contract for institution-initiated studies with CTN2 as an additional party. CTN2 does not charge participating institutions.
Institutional Review Board
To promptly obtain all required human subject approvals for multi-site clinical trials, where appropriate, efficient and agreeable, CTN2 facilitates central IRB regulatory review per sponsor preferences and provides information to participating institutions for their submission to local IRBs pursuant to local and institutional regulations, consistent with the preferences of PIs, participating institutions and funding sources.
Intellectual Property
As a subsidiary of UTRF, CTN2 arranges 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.”