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Research

About the CTSA Program

Asian scientist in lab

Transforming Clinical and Translational Research

The CTSA program is designed to address the development and implementation of national standards and best practices for the full range of translation, from basic discovery to clinical and community-engaged research. The program supports a national network of medical research institutions collaborating to transform how clinical and translational science is conducted nationwide.

CTSA Clinical Trials

CTSAs support a broad range of resources for clinical research, including clinical trials. However, NCATS authorization limits specific support for clinical trials through pilot projects and within training programs to trials only through the end of Phase IIA.

A Phase IIA clinical trial is a pilot study to evaluate the effectiveness 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 showing the effectiveness of an intervention.


CTSA-supported investigators are transforming basic discoveries into tangible improvements in human health through work to improve:

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

Program Evolution

Researchers in the Allergy and Clinical Immunology Division at the University of Michigan Medical SchooNIH 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.

In 2012, 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 they sought input through public workshops and other means. In June 2013, the IOM committee released its report, and NCATS Director Christopher P. Austin, M.D., issued a statement in response.

To provide guidance on the IOM’s recommendations, NCATS established the Advisory Council Working Group on the IOM Report: The CTSA Program at NIH. This group provided advice on changes to the CTSA program with a focus on establishing measurable goals and objectives. The working group issued a report on May 16, 2014.

Related Links

Contact

Petra Kaufmann, M.D., M.Sc.
Director, Division of Clinical Innovation


CTSA-Funded Institutions

Currently, about 60 medical research institutions in 30 states and the District of Columbia receive CTSA program funding to improve clinical and translational research nationwide.

CTSA-Funded Institutions

CTSA Map

CTSA Fact Sheet


CTSAs at Work

Finding a new way to treat and possibly prevent severe food allergies could improve the lives of millions. Find out what happened when scientists at five institutions that receive NIH funding, including through the CTSA program, took up the challenge.