 | Dr. Robert Sherwin |
The School of Medicine recently was awarded its largest National Institutes of Health (NIH) grant ever -- $57.3 million -- to accelerate the pace of bringing basic science research findings to clinical trial and then to patients, a process known as "translational research."
Dr. Robert Sherwin, who has been studying diabetes for his entire career, played a key role in the competitive application process. Sherwin, the C.N.L. Long Professor of Internal Medicine, is principal investigator on the grant, officially known as the Clinical and Translational Science Award (CTSA), and director of the new Yale Center for Clinical Investigation (YCCI), which is the core of the new initiative. Sherwin spoke recently about the grant.
In the old days, medicine was much more observational. You got ideas from the clinic, and then you might test this drug or that drug on an animal and later a patient. That was translational research back then. It's not so easy anymore. Now it requires the interaction of clinical people with people who have expertise in areas that you would never guess you would need. For instance, I would never have guessed that I would need a nuclear magnetic resonance center to do my diabetes research. I don't think most major health problems today can easily be solved by one person going to a lab and having a "Eureka" idea.
The irony is that the more detail we learned about disease on a cellular and molecular level, the more complicated the problem got, and the further away we were from the patient. Now we need the kind of interchange that involves people from different disciplines working closely together to tackle the more fundamental problems we face today. A much broader approach is required today.
The outpatient program and administrative offices of YCCI are located at 2 Church St. South, which is being renovated right now. There is also a hospital-based component that is located in Yale-New Haven Hospital.
The YCCI will help Yale researchers more effectively and efficiently take a finding from the laboratory to a clinical trial or from the clinical trial to the community. People have ideas, but most don't have the infrastructure to conduct clinical research. The YCCI staff can help them with protocol development, how to write an Institutional Review Board application and a consent form, how to deal with U.S. Food and Drug Administration (FDA) regulatory affairs, how to approach obtaining FDA approval to test a drug, how to interface with the community, how to develop a database, how to access different institutional resources.
We're hiring right now. We'll be operational before the end of the year.
Most people who start out in clinical research learn by osmosis. You learn on the run rather than through more formalized training. Clinical investigators need a structure. We plan to establish a group of faculty mentors who are senior faculty with a lot of experience in translation and community-based research. Their mission will be to guide junior faculty and students as they develop new careers in clinical research. Yale has a small Ph.D. program in clinical and translational research. The grant will double the size of the program and expand it to include more diverse trainees.
It's called the YCCI Scholars Program. We will make acceptance into the program competitive so we can bring in the most talented people. What is really exciting about clinical research is the opportunity to determine how discoveries in the lab can translate into a better understanding of disease, and ultimately prevent the disease or improve care for the patient. As a medical school, we need to train people who are going to make a difference in the population's health. You can have a much greater influence by finding out how to prevent health problems than by treating the problems.
The General Clinical Research Center on the 10th floor at Yale-New Haven Hospital has provided Yale scientists with outstanding clinical facilities and a superb nursing staff to support more intensive clinical studies. We want to broaden what is already in place to include research in other sites of the hospital, clinical trials and community health.
One of the most important aspects of the program is to create systems that help clinical researchers manage and retrieve their data so it can be appropriately analyzed. If you want to understand what genes are involved in a disease you have to create a DNA repository collected from population-based studies. If you are hoping to initiate a clinical trial you will need to make an assessment of your population size, your primary endpoints and how you are going to design this trial so that it has the best chance of being successful. The YCCI and its bioinformatics and biostatistics core resources can help researchers with these issues.
Kevin Herold's work in immunology is directed at preventing Type 1 diabetes, which is an autoimmune disease. What Kevin has done is look at an antibody that targets T-lymphocytes, the cells that destroy beta cells of the pancreas that make insulin. He has been successful in slowing down the process in new-onset diabetic patients by modifying the function of these T-cells so they are no longer harmful to those cells. Another area at Yale that offers promise of opportunities for translational research is depression. Information we have about changes in brain neurotransmission associated with depression may help develop drugs that will help modify those changes in brain function.
There are four types of pilot grants for which faculty can apply. The goal of these grants is to gather the preliminary data needed to apply for larger NIH or foundation grants. Grants will be in the following clinical research areas: support of junior faculty research; development of new research methodologies; fostering of community-based research projects; and initiating interdisciplinary research involving multiple investigators.
The long-term goal is to improve the health and care of our patients by making research a part of the day-to-day life of clinical practice at Yale School of Medicine.
-- By Jacqueline Weaver
T H I S
Sherwin: Broader research
approach needed today
People assume that translational research --that is, research aimed at developing new patient treatments -- has been going on all along. What is new about this approach?
What changed?
Where is the YCCI center located?
What will the YCCI do?
When will it be operational?
Another component of the CTSA grant involves attracting more people into the field of clinical research. How will you make that happen?
What is the new mentoring program called?
What clinical research is already in progress at Yale?
Yale's strengths in bioinformatics and biostatistics were one factor in receiving funding. Why was this important to the NIH?
What are a few examples of research that is ready to be taken to clinical trial?
There also will be grants for faculty to do research. How will those work?
What is the long-term goal?
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