NCATS Clinical and Translational Science Awards Program

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Under NCATS’ leadership, the Clinical and Translational Science Awards (CTSA) Program supports a national network of medical research institutions — called hubs ― that work together to improve the translational research process to get more treatments to more patients more quickly. The hubs collaborate locally and regionally to catalyze innovation in training, research tools and processes.

CTSA Program support enables research teams including scientists, patient advocacy organizations and community members to tackle system-wide scientific and operational problems in clinical and translational research that no one team can overcome. Program goals are to:

– 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 populations in translational research across the human lifespan;
– Innovate processes to increase the quality and efficiency of translational research, particularly of multisite trials; and
– Advance the use of cutting-edge informatics.

CTSA Program Clinical Studies
Through CTSA Program hubs, NCATS supports activities to test and develop innovative approaches to barriers in clinical research. One example is the, efficient recruitment of research participants and institutional review board (IRB) approvals for multisite clinical trials. Ongoing approaches include the following:

The Trial Innovation Network is a collaborative initiative composed of three key organizational partners:
– Trial Innovation Centers
– Recruitment Innovation Center
– 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. Features will include a single-IRB system, master contracting agreements, quality-by-design approaches and a focus on evidence-based strategies to recruitment and patient engagement.

The NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Platform is a single-IRB reliance platform for multisite clinical studies. The goal is to provide flexible resources that investigators nationwide can use to harmonize and streamline IRB review for their own multisite studies. The platform is based on the successful experiences of NIH central IRB initiatives and on a CTSA Program demonstration project using a single-IRB reliance model called IRBrely. The NCATS SMART IRB Platform is designed to be a flexible option that can be used to set up a central IRB for a network of many studies or a single IRB for one multisite study.

These and similar activities are intended to improve the quality and speed of clinical research in the CTSA Program network for a broad range of research studies, with the ultimate goal of bringing more evidence-based treatments to more patients more quickly.

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