Clinical research: the next generation

In 2006, former National Institutes of Health (NIH) Director Elias Zerhouni, M.D., launched the Clinical and Translational Science Awards (CTSA) program, part of his ambitious “Roa” initiative aimed at speeding the translation of biomedical laboratory discoveries to the bedsides of patients in need.

Much of the impetus for the CTSA program came from a widespread appreciation that the challenges of clinical and translational research had become so daunting that an entire generation of physicians and scientists were shying away from careers in these fields. In addition to standard medical and scientific training, today’s clinical and translational researchers often need special expertise in biostatistics, genetics, and computation, as well as knowledge of the strict regulations governing biomedical research with human subjects. To be truly successful, investigators must work comfortably in an emerging scientific culture based on interdisciplinary teams of physicians, scientists, and nurses. To reverse the alarming decline in the numbers of clinical and translational researchers, the CTSA program included a “Scholars” component, which provides support for education for the young scientists who will make up the next generation of investigators.

In a happy coincidence, a strategic plan commissioned by Dean Robert J. Alpern, M.D., completed in 2004, had targeted clinical and translational research as a priority for the School of Medicine, which led to the creation of the Yale Center for Clinical Investigation (YCCI). With educational, clinical, and community-based components, the YCCI’s structure mapped perfectly onto the goals Zerhouni hoped to accomplish with the CTSA, and the School of Medicine was named a recipient in the program’s first crop of grants—a $57.3 million award that remains the largest grant ever received by Yale in its 300-year history.

“When YCCI was established, I viewed the commitment to train the next generation as perhaps our most important goal, and we’re now beginning to reap the fruit of our efforts to educate young clinician-researchers,” says C.N.H. Long Professor of Medicine Robert S. Sherwin, M.D., YCCI director and an internationally recognized diabetes researcher. Over the past three years, Sherwin says, over 30 junior faculty holding M.D.s or Ph.D.s have received support through the CTSA as YCCI Scholars, and the program has given them the wherewithal to seek out and obtain about $42 million in research grants of their own. These YCCI Scholars have published more than 113 papers (with an additional 31 in press), given conference presentations, and collaborated with colleagues both nationally and internationally.

“The CTSA has provided crucial support to a broad group of people,” says Judy H. Cho, M.D., associate professor of medicine and YCCI’s co-director for education. “We have M.D.s without much research experience, and Ph.D.s with a lot of research experience who do not have adequate experience or exposure to clinical research issues to gather data for grant funding.”

In addition, the YCCI Scholars are eligible to receive a new Master of Health Science Research degree through a special YCCI program offering courses in epidemiology, biostatistics, informatics, practical and ethical issues in clinical and translational research, and topics in human investigation and grant writing.

“The important thing isn’t the degree, it’s the training,” says Eugene D. Shapiro, M.D., professor of pediatrics and of epidemiology and public health, who, along with Cho, is codirector for education at YCCI. “The new master’s program fills a need by providing training for young investigators in areas that are critical for successfully conducting clinical and translational research.”

Barbara Alving, M.D., director of the NIH’s National Center for Research Resources, the agency that oversees the CTSA program, says that educational opportunities that encourage physicians and scientists to venture beyond their comfort zones are invaluable. “The training that investigators receive through the CTSA Scholars program enhances their ability to work in interdisciplinary teams,” says Alving, “providing increased opportunities for collaboration and broader research perspectives.” According to Shapiro, these benefits are crucial to advancing medicine. “We’re trying to give these folks additional skills that will lead to success for them, and lead to success for humanity as a whole by providing new discoveries and better ways to deliver medical care,” he says. “Our educational programs give people more tools, but I think they also inspire people.”