NIH launches major program to transform clinical and translational science

10/11/05

Bethesda, Md. --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 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 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 for them. 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."

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