Last fall, as the H1N1 'swine flu' pandemic reached full swing, Gordon Bernard of Vanderbilt University Medical Center in Nashville, Tennessee started gearing up to test his idea that statins, which can dampen inflammation, might combat the disease. Whereas clinical trials often take years to get up and running, Bernard's study was approved in record time—two months.

Bernard credits his success to a program that helped him round up research partners and supported him in designing the trial—the Clinical and Translational Science Awards (CTSA) program. The program, launched in 2006 by the US National Institutes of Health (NIH), aims to speed up the process of transforming laboratory discoveries into therapeutic treatments by restructuring the translational research enterprise in the US.

Before the award program, anyone who wanted to conduct human studies faced a gauntlet of 18 institutional bodies at Vanderbilt, says Bernard, who directs the CTSA-funded Vanderbilt Institute for Clinical and Translational Research. Now, many of these groups report to one office. “The CTSA program has transformed the landscape” of clinical research, he says.

Four years on from the CTSA's inception, the NIH has given awards to 46 academic centers with the goal of spending $500 million annually to fund a total of 60 institutions by 2012. And this month, all 12 universities and hospitals that received the first CTSA grants are submitting their grant proposals for a five-year renewal.

It's difficult to quantify the success of the CTSA program directly because it's mainly designed to promote collaboration and provide support and infrastructure, rather than fund large projects. But many CTSA investigators boast that the program has hammered at the barriers to clinical studies, cutting into red tape, centralizing regulatory offices, training researchers and forging numerous new collaborations, programs and tools.

In the Boston region, five major universities and hospitals came together under the Harvard 'Catalyst' center, and in the Northwest, seven institutions in Seattle and community health organizations across five states banded together to form the CTSA-funded Institute of Translational Health Sciences. In Philadelphia, meanwhile, $65 million in CTSA funding spurred the expansion of the Institute for Translational Medicine and Therapeutics, through an alliance among its supporting institutions, including the University of Pennsylvania and Children's Hospital of Philadelphia. “Traditionally, institutions compete with a verve that inversely correlates with the distance that separates them,” says Penn's Garret FitzGerald, who heads the five-year award, initiated in 2006. “This was a big deal.”

FitzGerald's experience is echoed down the line by other CTSA leaders. “Competitors are now suddenly really engaged in working together,” says Anantha Shekhar, director of the Indiana Clinical and Translational Sciences Institute, which includes Indiana University, Purdue University and the University of Notre Dame, among others.

Lost in translation

Despite its successes, the program has been criticized for not addressing the earliest stages of the therapeutic pipeline. One main reason, many say, is that the CTSA has not had the power to change the academic reward system for bench researchers. “In academia, how do you develop the incentive for someone to do something?” asks Caren Heller, assistant dean for intercampus initiatives at Weill Cornell Medical College in New York who analyzed the 12 initial CTSA programs last year (Acad. Med. 84, 424–432, 2009). “You either give money or you promote them academically, through tenure and such. And the CTSA can't do either.”

FitzGerald points out that basic researchers face short grant cycles and come up for tenure quickly, both factors incompatible with the time involved in moving a potential therapy into a human study. Nevertheless, he sees that change is coming. “I think from the very beginning we knew we were undertaking an attempt at culture change,” FitzGerald says. “This is an extended issue, not a one- or two- or five-year project.”

Such institutional change should also include fostering links with industry and counting achievements such as number of commercial licenses, says Lesa Mitchell, vice president of advancing innovation at the Kauffman Foundation in Kansas City, Missouri. “It's time to start harvesting much of the basic research that is now in place,” she says. “It takes an entire ecosystem.”

Despite such challenges, Bernard says that the CTSA program benefits investigators at all stages of research by shoring up infrastructure and by luring funding from philanthropists and other outside sources.

As for Bernard's own trial of statins, the pandemic fizzled out before he had fully enrolled his subjects. But, like most CTSA heads, Bernard feels he is just getting started with transforming the system. “It's a work in progress,” he says. “You don't change institutions and agencies overnight.”