NCATS Eyes Changes To CTSA As Sequestration Limits Options

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Written by admin on May 1, 2014. Posted in Blog

The complete article can be found through Genetic Engineering and Biotechnology News.

NIH says it will improve its Clinical and Translational Science Awards (CTSA) program by strengthening its leadership, standardizing the evaluation of centers, increasing collaboration, ramping up its engagement with patient groups, and enhancing its transparency-based on recommendations made yesterday by theInstitute of Medicine(IOM).

But the NIH official whose center oversees CTSA acknowledged that implementing IOM's recommendations will be hampered by continuing across-the-board federal budget cuts or "sequestration" that may ultimately shrink the program.

Christopher P. Austin, M.D., director of the National Center for Advancing Translational Sciences (NCATS), said NIH will convene a working group of NCATS advisory board members and others to advise him on implementing IOM's recommendations swiftly.

Dr. Austin said NCATS will step up involvement in CTSA, setting goals and objectives as well as establishing a new working group of key stakeholdersto advise on implementation of the report's recommendations. The report also suggested CTSA promote collaborations beyond those of its 61 centers, such as with other institutions, patient groups, healthcare providers, the biopharma industry, and government agencies.

Engagement of patients, plus family members, should help CTSA carry out another IOM recommendation: Strengthening clinical and translational research related to child health.

"These things are absolutely critical to the success of the program, because the success of the program is going to be dependent on transforming the clinical and translational research ecosystem," Dr. Austin said during a phone conference with reporters.

He also voiced support for another recommendation IOM made in its 188-page report "The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research," paying for key efforts within and outside NIH toward increased collaborations-such as pilot studies and resource-sharing initiatives-through a new "innovations fund."

"This fund could be created through a set-aside mechanism within the CTSA Program that provides flexible funding to foster collaborative efforts that are pioneering and have great potential to accelerate clinical and translational research. Projects associated with this fund should include clear metrics and evaluation measures," the report stated.

The report did not spell out what those measures should be, and shied away from one possible answer.

"Although it would be ideal to evaluate the CTSA Program's impact on clinical care and public health, currently this is neither feasible nor realistic given the numerous driving forces that shape the research enterprise and the multitude of factors that affect health outcomes," it stated.

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