Clinical and Translational Science Awards Program

The NCATS Clinical and Translational Science Awards (CTSA) Program The CTSA Program: > 50 medical research institutions speeding the translation of research discovery towards improved patient care Enables research teams including scientists, patient advocacy organizations and community members to address system-wide scientific and operational problems in clinical and translational research that no one team can overcome. Program goals: Train and cultivate the translational science workforce Engage patients and communities in every phase of the translational process Promote the integration of special and underserved Innovate translational research quality and efficiency Advance the use of cutting-edge informatics

CTSA Program Consortium Activities Trial Innovation Network (TIN) Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Platform Accrual to Clinical Trials (ACT) Collaborative Innovation Suite of Awards Common Metrics Initiative

SMART IRB supports collaboration across the nation Any US human subjects research* Regardless of funding or funding status Use on a study-by-study basis Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB is a platform designed to ease common challenges associated with initiating multisite research and to provide a roadmap for institutions to implement the NIH Single IRB Review policy (effective date: January 25, 2018). Freely available for institutions and investigators, SMART IRB is an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multisite studies across the nation, regardless of funding status. 411 Participating Institutions and growing (including all CTSA Program hubs)

Accrual to Clinical Trials (ACT) Network Nationwide network sharing EHR data to increase participant accrual into the nation’s highest priority clinical trials. Vision: The vision of the ACT project is to create a CTSA federated network to increase accrual to clinical trials. Purpose: The fundamental purpose of the ACT project is to improve patient care and enable clinical trials and translational research. Goal: NCATS’ CTSA Program ACT is a national network of sites that share electronic health record (EHR) data with the goal of significantly increasing participant accrual to the nation’s highest priority clinical trials. Goal of the ACT Project The goal of the ACT project is to create a federated network of sites from the National Clinical and Translational Science Award (CTSA) Consortium to significantly increase participant accrual to the nation’s highest priority clinical trials. The project leverages the widespread implementation of the electronic health record (EHR) and the well-established extensive informatics and regulatory expertise within the CTSA Consortium. Leaders from CTSA programs across the country set the groundwork for the project and committed to participate in the creation of this national federated network. A major strength of the NCATS CTSA program is its networking of academic medical centers across the nation. This was recognized by the Institute of Medicine’s report of its objective evaluation of the CTSA program, which stated that the CTSA program should “…establish a national network that will accelerate the development of new diagnostics, therapeutics, and preventive interventions and, at the same time, drive innovation in clinical and translational research methods, processes, tools, and resources.”1 Many individual CTSAs are capable of identifying and engaging local patients for clinical trials and research studies through their EHR. The challenge for the CTSA consortium is to develop the informatics tools, regulatory infrastructure, and governance structures that are required to leverage the EHR across CTSA sites and thereby across the nation. If our goal is accomplished, we will revolutionize clinical and translational research across America and position America to become the leading “go to” site for human clinical trials by all Biotech and Pharma companies.

Collaborative Innovation Suite of Awards Promote collaborative pilot studies and initiatives addressing roadblocks in translational research Engage a combination of CTSA Program hubs

Selected projects