About the CTSA Program
A Focused Mission
NCATS’ Clinical and Translational Science Awards (CTSA) program seeks to 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.
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.
Moving Beyond Academic Homes for Clinical Research
NIH 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.
The initial phase of the program focused on re-engineering existing capabilities at medical research institutions and developing new resources in the areas of clinical and translational research training, community outreach and informatics.
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.
The CTSA Consortium is pursuing 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.
This next phase of the CTSA program aims to transform clinical research across the nation by:
- Building a better bridge between pre-clinical and clinical science;
- Providing a foundation of shared resources that could reduce costs, delays and difficulties experienced in clinical research, including trials;
- Developing partnerships for research to be better integrated across sites and into ongoing patient care; and
- Strengthening strategies for engaging patient communities into the research process.
The NIH has commissioned the Institute of Medicine (IOM) to assemble an ad hoc expert committee to evaluate the CTSA program. Committee members are reviewing existing evaluations and stakeholder input, and are seeking input through public workshops and other means. In June 2013, the IOM committee will release a report with recommendations. Visit the IOM website to learn more.
Sharing a Common Vision to Transform Clinical and Translational Research
The CTSA program provides infrastructure support to facilitate translational research, to promote the training and career development of translational researchers, and to develop innovative methods and technologies to strengthen translational research. These sites form a national consortium that shares a common vision of improving human health by transforming the research and training environments for clinical and translational science.
Through the CTSA Consortium, investigators at CTSA-supported institutions work together to better address national health issues. By focusing on data-sharing, multi-trial regulatory hurdles, patient recruitment, communication and other key function areas of research, the consortium strives to re-engineer the clinical and translational research process. Learn more about the Consortium’s progress and its successes.
Currently, about 60 medical research institutions in 30 states and the District of Columbia are active members of the CTSA Consortium.
Jessica Mast, R.N., assists during an ultrasound performed by Zhaohui Gao, Ph.D., on study volunteer Josh Miller for one of many cardiac research studies at Penn State Hershey. Photo courtesy of Penn State College of Medicine/Darrell Peterson
CTSA Fact Sheet
Learn more about the innovative discoveries made by CTSA-funded institutions across the country.
CTSA Fact Sheet (192KB PDF)