Designed to spur the transformation of clinical and
translational research, a new NIH grant program called Institutional
Clinical and Translational Science Awards (CTSA) was announced
on Oct. 12 by NIH director Dr. Elias Zerhouni. The ultimate goal
of the program, open to qualifying academic health centers across
the nation, is to develop treatments more efficiently and deliver
them more quickly to patients.
"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 CTSA program is an NIH Roadmap for Medical Research initiative
and will be led by the National Center for Research Resources.
The awards 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, it will foster original research in developing clinical
methodologies such as informatics, laboratory methods, other technology
resources and community-based capabilities.
"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."
Developed with input from the research community and in consultation
with the trans-NIH CTSA project team, funding for the new initiative
will come from the Roadmap budget and existing clinical and translational
programs. This will be accomplished entirely through redirecting
existing resources, including Roadmap funds.
|"Ultimately, patients will be better served because new prevention
strategies and treatments will be developed, tested and brought
into medical practice more rapidly."
"We are taking great care to preserve the investigator-initiated
research support pool in these times of constrained budgets," Zerhouni
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.
"Given the increasing complexity of clinical research methodology
and technology, it is crucial that we encourage academic institutions
to find more creative ways of preparing physician- scientists and
developing multi-disciplinary approaches so we can more quickly
transform discoveries into treatments that benefit patients," said
Dr. Stephen Katz, director of the National Institute of Arthritis
and Musculoskeletal and Skin Diseases, and advisor to the Roadmap
initiative Re-engineering the Clinical Research Enterprise.
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 institutions to develop the discipline
of clinical and translational science by providing them with the
resources to create a defined 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 on 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
Dr. Barbara Alving, NCRR acting director. "The intent is to provide
the much-needed catalyst to increase the efficiency and speed of
clinical and translational research."
To coincide with the CTSA launch, Zerhouni published a Sounding
Board [opinion] article titled, "Translational and Clinical Science — Time
for a New Vision," in the Oct. 13 issue of the New England
Journal of Medicine. In the article, Zerhouni said, "There
is good reason to believe that the scope of knowledge and expertise
needed to be an effective translational or clinical scientist can
no longer be acquired 'on the job,' as was done in the past.there
is a call for training in a wider range of skill sets that span
biomedical and behavioral sciences and make use of far more advanced
and more complex resources and methods than ever before." The full
text of the article can be found at http://content.nejm.org/cgi/reprint/NEJMsb053723v1.pdf.
The CTSA Request for Applications (RFA) calls for submissions
by Mar. 27, 2006. Initial awards are expected to be made by fall
2006. The RFA and other information about the program are available