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Vol. LVII, No. 22
November 4, 2005
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NIH Launches Program to Transform Clinical, Translational Science

On the front page...

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."

Continued...

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
"Ultimately, patients will be better served because new prevention strategies and treatments will be developed, tested and brought into medical practice more rapidly."
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.

"We are taking great care to preserve the investigator-initiated research support pool in these times of constrained budgets," Zerhouni said.

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 at www.ncrr.nih.gov/clinicaldiscipline.asp.

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