|NIH Launches Major Program to Transform Clinical and Translational
Bethesda, Maryland — National Institutes of Health (NIH)
Director Elias A. Zerhouni, M.D., today announced a new program designed to spur
the transformation of clinical and translational research in the United States,
so that new treatments can be developed more efficiently and delivered more quickly
“We are truly at a crossroads in medicine,” Zerhouni said. “The scientific advances
of the past few years, such as the completion of the Human Genome Project, dictate
that we act now to encourage fundamental changes in how we do clinical research,
and how we train the new generations of clinician scientists for the medical
challenges of this century.”
The Institutional Clinical and Translational Science Awards (CTSAs) program,
unveiled today in The New England Journal of Medicine (NEJM), is designed
to energize the discipline of clinical and translational science at the academic
health centers around the country.
“This program will give research institutions more freedom to foster productive
collaboration among experts in different fields, lower barriers between disciplines,
and encourage creative, new approaches that will help us solve complex medical
mysteries,” said Zerhouni. “Ultimately, patients will be better served because
new prevention strategies and treatments will be developed, tested, and brought
into medical practice more rapidly.”
The grants will encourage institutions to propose new approaches to clinical
and translational research, including new organizational models and training
programs at graduate and post-graduate levels. In addition, they will foster
original research in developing clinical research methodologies, such as clinical
research informatics, laboratory methods, other technology resources and community-based
research capabilities. Potential benefits to patients include: new medical monitoring
devices that they can use in their own homes; improved methods for predicting
the toxicity of new drugs in specific individuals; and a seamless and safe experience
for those who participate in clinical trials.
NIH plans to award four to seven CTSAs in FY 2006 for a total of $30 million,
with an additional $11.5 million allocated to support 50 planning grants for
those institutions that are not ready to make a full application. NIH expects
to increase the number of awards annually so that by 2012, 60 CTSAs will receive
a total of approximately $500 million per year. The CTSA program is an NIH Roadmap
for Medical Research initiative and will be administered by the National Center
for Research Resources (NCRR), a component of the NIH. Funding for the new initiative
will come in part from the Roadmap budget and existing clinical and translational
programs. This will be accomplished entirely through redirecting existing resources,
including Roadmap funds.
“We are taking great care to preserve the investigator-initiated research support
pool in these times of constrained budgets,” Zerhouni said.
For the purposes of this initiative, NIH is defining clinical research as studies
and trials that involve human subjects. Translational research is to include
two segments of the research continuum. The first is the process of applying
discoveries made in the laboratory, testing them in animals, and developing trials
and studies for humans. The second concerns research aimed at enhancing the adoption
of best treatment practices into the medical community.
The CTSA program will encourage the development of the discipline of clinical
and translational science by providing the resources for the creation of a redefined
academic home. The program will allow for local flexibility so that each institution
can determine whether to establish a center, department, or institute, or other
interdisciplinary structure, depending upon local and regional circumstances.
“We hope to increase the number of translational and clinical investigators
by providing interdisciplinary training in a dedicated intellectual environment
that offers clear career pathways, combined with opportunities to develop new
approaches to clinical research,” said Barbara M. Alving, M.D., NCRR Acting Director. “We
hope this CTSA program provides the much-needed catalyst to increase the efficiency
and speed of clinical and translational research.”
The Request for Applications (RFA) calls for submissions by March 27, 2006.
Initial awards are expected to be made by Fall 2006. The RFA is available at www.ncrr.nih.gov.
The CTSA initiative was developed with extensive input from the research community,
including a day-long conference on May 23, 2005. For more information, visit http://www.ncrr.nih.gov/clinicaldiscipline/CTSA052305meeting.asp.
To view a fact sheet on the NIH Clinical and Translational Science Awards (CTSA),
The National Center for Research Resources, a part of the National Institutes
of Health, strengthens and enhances the research environments and tools used
by scientists who are working to prevent, detect, treat, and cure a wide
range of diseases. By developing and funding essential research resources,
such as imaging and bioinformatics technologies, preclinical models, and
clinical research centers, NCRR contributes to major medical discoveries
made by scientists supported by the National Institutes of Health. Additional
information about NCRR can be found at http://www.ncrr.nih.gov.
About the NIH Roadmap for Medical Research
The NIH Roadmap for Medical Research is a series of far-reaching initiatives
designed to transform the Nation's medical research capabilities and speed
the movement of scientific discoveries from the bench to the bedside. It
provides a framework of the priorities the NIH must address in order to optimize
its entire research portfolio and lays out a vision for a more efficient
and productive system of medical research. Additional information about the
NIH Roadmap can be found at http://nihroadmap.nih.gov.
The National Institutes of Health (NIH) — The Nation's Medical Research
Agency — includes 27 Institutes and Centers and is a component of
the U. S. Department of Health and Human Services. It is the primary Federal
agency for conducting and supporting basic, clinical, and translational medical
research, and it investigates the causes, treatments, and cures for both common
and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.