Clinical psychiatrist Barbara Gracious had a month to spare over the summer while transitioning to her new job at Ohio State University in Columbus. But, instead of jetting off to a vacation spot, she packed her bags for Bethesda, Maryland, home of the US National Institutes of Health (NIH) Clinical Center, to go on sabbatical.

This past summer, Gracious, together with three other researchers, was part of a pilot training program in clinical trial management. The investigators took courses in introductory protocol writing, patient tracking and safety management, among other issues. They also met with program officers at the NIH and made contacts at the US Food and Drug Administration (FDA) to better understand regulatory issues associated with clinical research.

Beyond the coursework, Gracious says the experience provided the perfect networking opportunity. “I was able to meet with other researchers who will be co-investigators or consultants on my planned work... and provide input or share laboratory techniques to better the science for our patients,” she says.

Clinical Center director John Gallin says the program was set up to foster these kinds of connections, as well as to help researchers deal with the management and bureaucratic aspects of running a clinical trial. “There's a real need to demystify the federal bureaucracy and regulatory components that have become demanding for investigators,” he says.

Giselle Sholler, a pediatric oncologist from the University of Vermont in Burlington who was also part of the pilot program, was no novice to clinical grant writing, having already netted four NIH clinical trials over the past four years. But as her work expands to include more collaborations with other institutions, she wanted more formal training in how to most effectively budget and use resources for larger trials.

Reflecting on her sabbatical experience thus far (she expects to complete the program next June), Sholler thinks the experience gave her a better idea of what to expect from government regulators. “That's not something we're taught in medical school,” she says.

Beyond training to help ensure that medical research programs are safe, ethical and efficient, the Clinical Center's sabbatical program also aims to familiarize researchers with the business side of running clinical trials, including planning budgets and negotiating with subcontractors. James Bost, a biostatistician who manages large clinical trials at the University of Pittsburgh says this knowledge is crucial to the success of a trial.

“You get to the point where you can't keep everything in house,” says Bost, who is not affiliated with the sabbatical program.

After the successful pilot program, the Clinical Center is now accepting applications year round for new participants from anywhere in the world. Two of the pilot participants were from Russia, and Gallin says the program “has appeal and applicability to both US and international investigators.”