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. 2018 Aug;2(4):187-192.
doi: 10.1017/cts.2018.319. Epub 2018 Nov 27.

A collaborative, academic approach to optimizing the national clinical research infrastructure: The first year of the Trial Innovation Network

Gordon R Bernard  1 , Paul A Harris  1 , Jill M Pulley  1 , Daniel K Benjamin  2 , Jonathan Michael  3 , Daniel E Ford  4 , Daniel F Hanley  5 , Harry P Selker  6 , Consuelo H Wilkins  7
Affiliations

A collaborative, academic approach to optimizing the national clinical research infrastructure: The first year of the Trial Innovation Network

Gordon R Bernard et al. J Clin Transl Sci. 2018 Aug.

Abstract

Inefficiencies in the national clinical research infrastructure have been apparent for decades. The National Center for Advancing Translational Science (NCATS) -sponsored CTSA program is able to address such inefficiencies. The Trial Innovation Network (TIN) is a collaborative initiative with the CTSA Program and other NIH Institutes and Centers (ICs) that addresses critical roadblocks to accelerate the translation of novel interventions to clinical practice. The TIN's mission is to execute high quality trials in a quick, cost-efficient manner. The TIN awardees are composed of: three Trial Innovation Centers (TICs), the Recruitment Innovation Center (RIC), and the individual CTSA institutions that have identified TIN Liaison units. The TIN has launched a national scale single (central) IRB system, master contracting agreements, quality-by-design approaches, novel recruitment support methods, and applies evidence-based strategies to recruitment and patient engagement. The TIN has received 113 submissions from 39 different CTSA institutions and 8 non-CTSA Institutions, with projects associated with 12 different NIH ICs across a wide range of clinical/disease areas. Already more than 150 unique health systems/organizations are involved as sites in TIN related multisite studies. The TIN will begin to capture data and metrics that quantify increased efficiency and quality improvement during operations.

Keywords: CTSA program; Trial Innovation Network; clinical trials; innovation; multisite clinical research.

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Conflict of interest statement

Disclosure statement: No conflicts of interest exist.

Figures

Fig. 1
Fig. 1
National Institutes of Health (NIH) Institutes and Centers (ICs). Multiple NIH ICs are associated with studies using the Trial Innovation Network.
Fig. 2
Fig. 2
Stakeholder engagement. As of May 18, the Network has received proposals from 39 different Clinical and Translational Science Award institutions. Note: These numbers do not include the pilot testing/demonstration projects (total of 11) conducted among the Trial Innovation Centers sites as systems and services were being established.
Fig. 3
Fig. 3
Landscape of resources supporting projects. A range of services is represented in the support provided to Trial Innovation Network studies to date; numbers denote the number of projects receiving each type of service. Each request is counted individually (even for proposals requesting multiple services). CIRB, Central Institutional Review Board.
Fig. 4
Fig. 4
Satisfaction related to the initial consultations. Satisfaction survey responses have been received from 16 study teams.
See this image and copyright information in PMC

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