Trial Innovation Network

Jeffrey Burns, M.D., director of the Frontiers: University of Kansas Clinical and Translational Science Institute's Participant and Clinical Interactions Resources Program, and its Clinical and Translational Science Unit, and director of the Alzheimer's and Memory Program, monitors Howard Kemper, a participant in the Brain Aging Project. The program is studying the relationship between fitness and Alzheimer's disease. Mr. Kemper, who does not have Alzheimer's disease, is participating in this study as a "healthy" control. (Donna Peck Photo)

NCATS has built the Clinical and Translational Science Awards (CTSA) Program on the strength of more than 50 unique academic medical centers (called hubs) nationwide. NCATS relies on the individual strengths of the CTSA Program hubs and partners with them to develop and implement innovative, collaborative solutions intended to transform clinical and translation research. Together, these efforts address common areas of need that call for collaborative solutions, including:

• Training and cultivating the translational science workforce;
• Engaging patients and communities in every phase of the translational process;
• Promoting the integration of special and underserved populations in translational research across the human lifespan;
• Innovating methods and processes to increase the quality and efficiency of translational research, particularly of multisite trials; and
• Advancing the use of cutting-edge informatics.

Overview

The Trial Innovation Network is a new collaborative initiative within NCATS’ CTSA Program composed of three key organizational partners:

• Trial Innovation Centers (TICs)
• Recruitment Innovation Center (RIC)
• CTSA Program hubs

NCATS’ vision for the Trial Innovation Network is to address critical roadblocks in clinical trials and to accelerate the translation of novel interventions into life-saving therapies. The network will focus on operational innovation, operational excellence and collaboration while leveraging the expertise, diversity and broad reach of the CTSA Program. Features will include a single institutional review board system, master contracting agreements, quality-by-design approaches, and a focus on evidence-based strategies to recruitment and patient engagement.

The goal is not only to execute trials better, faster and more cost-efficiently, but also to be a national laboratory to study, understand and innovate the process of conducting clinical trials.

Current Awardees

Current TIC and RIC awardees are:

TICs

Center for Innovative Trials in Children and Adults (TRIDENT)

Institutions: Duke University and Vanderbilt University Medical Center
Principal Investigators: Daniel K. Benjamin, Jr., M.D., Ph.D. (Duke), and Gordon R. Bernard, M.D. (Vanderbilt)

Utah Trial Innovation Center

Institution: University of Utah
Principal Investigator: Jonathan Michael Dean, M.D.

Johns Hopkins-Tufts Trial Innovation Center

Institutions: Johns Hopkins University and Tufts University
Principal Investigators: Daniel F. Hanley, M.D. (Johns Hopkins), Daniel E. Ford, M.D. (Johns Hopkins), and Harry P. Selker, M.D. (Tufts University)

RIC

Improving Clinical Trial Education, Recruitment and Enrollment at CTSA Hubs (I-CERCH)

Institution: Vanderbilt University Medical Center
Principal Investigators: Paul A. Harris, Ph.D., and Consuelo H. Wilkins, M.D.

At the launch of the network in fall 2016, Trial Innovation Network investigators will work to build key elements of the initiative. Early plans include consultations to build partnerships with other NIH Institutes and Centers, the broader scientific community and other stakeholders. As the network evolves and gains momentum, the goal is to launch network-led clinical trials collaboratively with other partners in 2017.