New Clinical Research Initiative at Yale: Center provides tools for YMG clinicians to test new therapies

[July 2008] The Yale School of Medicine has a long tradition of encouraging bench-to-bedside research through the support of a wide range of interdisciplinary clinical trials. More than 100 research projects are now in progress exploring laboratory discoveries related to such diseases as schizophrenia, lung disease, stroke, multiple sclerosis, breast cancer, AIDS, autism, obsessive compulsive disorder, prostate cancer and leukemia.

An ambitious new initiative at the School of Medicine, funded by the largest-ever grant to the school, intends to make it easier for clinicians to conduct trials and for healthy volunteers or patients to participate. Capitalizing on Yale’s strengths in basic science, education and community-based research, the new Yale Center for Clinical Investigation (YCCI) streamlines the process for investigators to design and implement research studies and gives them access to state-of-the-art biomedical technologies, with the ultimate goal of enabling faster and more efficient development of new therapies.

“Our hope is that this will be a shot in the arm for a significant expansion of clinical research at Yale,” said Robert S. Sherwin, MD, the C.N.H. Long Professor of Medicine and director of YCCI. Tesheia Johnson, MBA, MHS, associate director for clinical research at the medical school, is the new center’s chief operating officer.

YCCI, represents a major expansion of the General Clinical Research Center housed at Yale-New Haven Hospital. The Center will have two locations, one for intensive studies that require patients to remain in the hospital, and a second at 2 Church Street South, which will focus on community-based and outpatient research. The new facility on Church Street South, with better parking and easier access, will open up new space for research, Johnson said. “This is the first time we will have an accessible space for research volunteers.”

YCCI’s mission is to streamline the process for investigators as they design and implement research studies, helping them through the complex regulatory requirements of local, state and federal agencies and funding entities. “It isn’t easy  to embark on a clinical study any more,” Sherwin said. “We’re trying to create an infrastructure to make it easier for investigators to get through the process.”

A key component of the center is training for clinicians so they can learn to design and conduct scientifically credible studies. “People who do clinical research get medical training, but often do not have sufficient training to deal with the science side,” Sherwin said.

To fill that gap, YCCI’s educational core is based in the Investigative Medicine Program, which offers advanced training to MD fellows starting careers in translational or clinical research. In April the first group of YCCI Scholars, comprising 15 junior faculty members, were named. They will receive salary support and funding to devote at least 75 percent of their time to clinical or translational research. They will also receive mentoring from established clinical scholars.

Other plans call for bringing clinical, basic science and public health researchers together on projects, providing support for junior faculty interested in translational research, encouraging joint projects between community and Yale physicians and creating a website that will keep community members informed about what’s happening at the center and how they can get involved.

“YCCI finally creates structure for clinical research activities of the clinical faculty,” said David J. Leffell, MD, deputy dean for clinical affairs for the medical school and director of the Yale Medical Group. “One of the big challenges for clinical trials is coordinating the many pieces, ranging from regulatory operations to managing the clinical trial once it’s up and running. In the past, each faculty member was left to fend for him or herself. YCCI will eliminate a lot of those barriers.”

The center is funded under a five-year, $57.3 million Clinical and Translational Science Award from the National Institutes of Health. It is part of a major national initiative known as the NIH Roadmap for Medical Research, which is intended to simplify the process for researchers to move laboratory discoveries into human studies. Key participants in the Yale grant are the Yale schools of Nursing and Public Health and the Combined Program in the Biological and Biomedical Sciences.

“Ultimately, we need to translate basic science to the clinical arena, and then from clinical to the community,” Sherwin said. “If we don’t do that, we’re only publishing papers, not improving health.”

For more information about YCCI visit http://ycci.yale.edu.