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NCATS Weighs How to Integrate and Focus CTSA Program

By Matt Jones

NEW YORK (GenomeWeb News) – As the National Institutes of Health works to assemble the new National Center for Translational Sciences, it is considering and seeking public input on how to best integrate and enhance one of the center's flagship programs, the Clinical and Translational Science Awards.

NCATS, which has taken over much of the portfolio of the former National Center for Research Resources and which was funded this year with $577 million, said in a recent notice that it is looking into ways it can "further strengthen" the CTSA program to meet its clinical and translational goals. To that end, a transition working group drafted recommendations on how to better the program and the NCATS now is seeking public and stakeholder comments on how it should structure and position the program to support development of novel designs, methods, and research to better focus on the translational pipeline.

The CTSA program exists to provide infrastructure, training, and career development to translational scientists, and to develop new methods and tools for translational research. Launched in 2006, the CTSA program now has 60 medical research institutions in its consortium, and last year it pumped $460.6 million into the CTSA sites.

"The CTSAs support the innovation and partnerships necessary to bridge the traditional divides between basic research and medical practice," NIH Director Francis Collins said when the new funding was announced last June. "The combination of resources and collaboration made possible by these awards is essential for developing and delivering new treatments and prevention strategies."

The goals of the CTSA program and the mission of NCATS are "a very natural marriage," Josie Briggs, acting director of the Division of Clinical Innovation at NCATS, told GenomeWeb Daily News yesterday. "The NCATS mission is to improve methods and techniques and technology for improving and strengthening translational sciences. There is enormous synergy and overlap with what the CTSAs have done from the beginning."

NIH leadership set up the transitional working group before the new NCATS center was approved in order to recommend a strategy for how the CTSA program could be best used to support translational science.

"The main message that came out of the transition working group was that the CTSA program was very strong… and that it had made enormous progress in creating an academic home for translational sciences and in strengthening translational processes," Brigg said.

She added that the working group agreed that the CTSA's support for training new scientists to inhabit this academic home for translational science has been the program's most notable success so far. However, the group found that the CTSA program could use some tweaking because it has not yet succeeded in effectively coordinating the consortium member's individual strengths on a national level.

The major impediment to that kind of coordination, the group found, has been the absence of dedicated funds and the need to divert funds from institutional activities to support activities in the consortium. The working group recommended that the CTSA program continue to provide its support across a "full spectrum of translational research while encouraging CTSA institutions to develop their unique strengths."

The group also indicated that the existing funding mechanism does not create enough incentive for the CTSAs to develop innovative approaches that focus on specific areas, and recommended that future RFAs should allow the CTSAs to "become more differentiated, and to focus on their own institutional strengths," Briggs explained.

Encouraging CTSA sites focus more on their strengths, while turning to their consortium partners for support in areas where they do not excel, would minimize redundant efforts and would strengthen the consortium as a whole. To that end, the CTSA program funds should be dedicated to consortia activities at the regional and national levels, the group recommended.

"Improving methods and science throughout the entire spectrum of translational work is an important part of the CTSAs, but perhaps not every CTSA needs to do it all," Briggs added. "The question of how to incentivize or change the expectations of the CTSAs so that there is a possibility of more differentiation, while still maintaining the [program's] broad mission," is one of the main questions NCATS is seeking broad public input on," she explained.

NCATS also should "monitor the landscape for critical translational research needs" and should keep funding reserved for addressing these needs as they arise, the working group advised.

Briggs pointed out that although the CTSA program is six years old now, it was only in 2011 that it reached its full size, and she said that the consortium activities in some areas have been "really quite impressive."

She added that by encouraging centers to differentiate more would enable them to have a broader range of shared resources, so that a member institution that is strong in computational biology could share its strength with others, and lean on them for support in their unique specialty areas.

Briggs explained that the working group review, the recommendations, and the effort to gather stakeholder input on how to implement the CTSA program are all aimed at keeping fine tuning the alignment that already exists between NCATS and the CTSAs.

"The strengths of the CTSA program have been in human subjects research, and translational science is all about human subjects research," she explained. Those who are overseeing human subject research are aware that the processes are cumbersome, slow, and expensive.

"The capacity of the CTSA program, and the work they have already done, to explore the places where there are roadblocks, the places where implementation of clinical trials are too slow… and the attention to the roadblocks and barriers to efficient implementation of human subjects research is really central to NCATS mission and indeed to the CTSAs," Briggs said.

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