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About the CTSA Program

A Focused Mission

Doctor with patient in magnetic resonance imaging machine

NCATS’ Clinical and Translational Science Awards (CTSA) program helps strengthen the full spectrum of translational research. Institutional CTSA awards are the centerpiece of the program, providing academic homes for translational sciences and supporting research resources needed by local and national research communities to improve the quality and efficiency of all phases of translational research. Institutional CTSAs also support the training of clinical and translational scientists and the development of all disciplines needed for a robust workforce for translational research.

CTSA Clinical Trials

CTSAs support infrastructure and resources for clinical research, including clinical trials. However, specific support for clinical trials through pilot projects and within training programs is limited by NCATS authorization to trials only through the end of Phase IIA. A Phase IIA clinical trial is a pilot study to evaluate the efficacy and safety of an intervention in patients with the disease or condition to be treated, diagnosed or prevented. These studies may focus on participant population characteristics, dose response, dose frequency or other characteristics related to safety or efficacy. Phase IIA trials are not considered pivotal trials of efficacy.

CTSA-supported investigators are transforming basic discoveries into tangible improvements in human health by focusing on:

  • Data-sharing and informatics tools
  • Translational research training
  • Innovative collaborations
  • Multi-study regulatory hurdles
  • Patient recruitment
  • Other key areas of research involving people

CTSA-funded institutions pursue goals that address the development and implementation of national standards, best practices and infrastructure support for the full range of translation, from basic discovery to clinical and community-engaged research.

Moving Beyond Academic Homes

Researchers performing an ultrasound on a patientNIH launched the CTSA program in 2006 to:

  • Create academic homes for clinical and translational research.
  • Provide investigators and research teams with research cores, tools and a local environment that encourages and facilitates the conduct of clinical and translational research, including with community and industry partners.
  • Train the scientific workforce needed for the translational sciences.

NCATS released a Request for Information (RFI): Enhancing the Clinical and Translational Science Awards Program in March 2012. Based upon stakeholder feedback, NCATS published a summary of more than 130 responses to the RFI. Much of this feedback — along with recommendations from the NIH CTSA/NCATS Integration Working Group and input from CTSA principal investigators — also is guiding NCATS in determining the future direction of the CTSA program.

In 2012, the NIH commissioned the Institute of Medicine (IOM) to assemble an ad hoc expert committee to evaluate the CTSA program. Committee members reviewed existing evaluations and stakeholder input, and sought input through public workshops and other means. In June 2013, the IOM committee released its report. Read the NCATS Director’s Statement about the report.

Related Links

CTSA-Funded Institutions

Currently, about 60 medical research institutions in 30 states and the District of Columbia are active members of the CTSA Consortium.
CTSA-Funded Institutions

CTSA Progress Reports

CTSA Progress Report 2011 Home Page

CTSA Progress Report 2009–2011

CTSA Progress Report 2006–2008
(PDF 1.4MB)