"Tennessee's state-wide multi-site clinical trial facilitator - Site operated, academically supported, powered by a robust research enterprise data warehouse, for superior performance and increased sponsor engagement."
Who We Are
PIs must recruit and create the best studies available, and at the same time ensure rapid start-up and financial viability of trials. Academic affiliation and university participation are the best way to ensure the former, while individual institutions have historically been more accomplished in expediting study start-up and budgeting.Securing credit for research performed by UTHSC and other PIs at Participating Institutions enhances UT’s national standing.
Actively supported by leadership and PIs in all UTHSC colleges, the Clinical Trials Network of Tennessee (CTN2) is a 501(c)(3) subsidiary of the UT Research Foundation (UTRF), governed by a board representing participating institutions (including hospital systems and large practice plans) to enhance state-wide multi-site clinical trials involving UTHSC faculty and participating institutions. CTN2 leverages the best of both worlds– it provides 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.
STRUCTURE & CONTRACTS
CTN2 is an objective-driven 501(c)(3) Tennessee non-profit corporation, organized as a subsidiary of and funded through UTRF, the sole corporate member. CTN2 is governed by a Board of Directors which includes a representative from each participating institution, nominated by the institution and elected by UTRF.
CTN2 markets its network of participating hospitals and practice groups, and access to TN-EDW and statewide trial patients to clinical trial sponsors.
To accommodate the source of clinical trials within each participating hospital and practice group, CTN2 contracts in one of two equally valuable ways:
Site-Initiated Studies: Where the participating institution takes the lead in communication and negotiation with the study sponsor, CTN2 is a party to the contract for funds flow through to the participating institution, to provide a mechanism for UTHSC to accrue credit for research expenditures. Participating institution retains absolute discretion to include CTN2 on site-initiated studies, or to contract solely with the sponsor.
However, the participating institution always retains the right to participate directly with CTN2 in talks with the sponsor and to consent to any exceptions to the terms of its CTN2 MCTA. As with Site-initiated Studies, the resulting clinical trial agreement is a three-party contract among sponsor, CTN2 and the participating institution. Participating Institution retains sole discretion to elect to participate in each CTN2-initiated study.
CTN2 is not interested in “taking credit” from participating institutions for studies that come to the institution or its investigators. CTN2 objectives are met equally well, whether a study is contracted as Site-initiated or CTN2-initiated.
For Either Type Contract:
Participating institutions and investigators review protocols, establish budgets, and individually review and sign off on each study agreement. The decision to contract for a study is at the sole discretion of the participating institution. CTN2 does not require sites to take on studies nor does CTN2 have contracting authority for network sites.
CTN2-initiated Studies: Typically, in situations where the Sponsor comes directly to CTN2 (e.g., through TriNetX) or for multi-site studies, CTN2 takes the lead in communication and negotiation with the clinical trial sponsor and the participating institution, relying on CTN2’s MCTA with the participating institution as the basis for discussion.