Fall 2007
First Gillings Innovation Laboratory aims to improve clinical trials
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| Joeseph Ibrahim |
Clinical trials are typically the final testing stages for drugs, devices, behavior modification programs or any other experimental treatment methodology prior to marketing or widespread implementation. Clinical trials are necessary to mediate adverse effects and determine effectiveness but often span months to years and may not yield as precise or useful results as intended.
In an effort to develop better ways to design and conduct clinical trials, the UNC School of Public Health has established the Center for Innovative Clinical Trials. Faculty and other collaborators within the center will develop new methods of collecting and analyzing data from clinical trials and then efficiently and rapidly make these scientific advances available to researchers, practitioners, the biomedical community and the public as a whole.
Joseph G. Ibrahim, alumni distinguished professor of biostatistics in the School of Public Health and director of the biostatistics core at the Lineberger Comprehensive Cancer Center, will head the center. “We want to find ways to speed up and improve the clinical trial process and get results faster, but we want them to be more precise and useful in determining if the treatment is effective, and if so, for which patients,” he said. “The ultimate goal is better health care.”
With an interdisciplinary focus and theme, the center will bring together faculty from several University departments as well as collaborators from industry and other universities to engage in both methodological and applied research in clinical trials design, analysis and evaluation. Experts in biostatistics, statistics, medicine, epidemiology, maternal and child health, nutrition, environmental health, health policy, economics, business, dentistry, psychology, psychiatry, nursing, biology and chemistry will contribute their expertise to the center’s initiatives.
Ibrahim said he believes using different statistical methods, both when designing trials and when analyzing the results, can help avoid situations where marketed medicines or treatments are found to have significant problems or side effects for many patients.
“I think we could make a real difference in clinical trials,” Ibrahim said. “Right now, trials are primarily designed to pay special attention to one primary endpoint in both the design and analysis stage. We are working on more of a multi-dimensional approach, where we look at several endpoints at once. We believe this will make adverse events, toxicity, treatment interventions and quality of life more apparent earlier on in the trials.”
The Center for Innovative Clinical Trials is the first Gillings Innovation Laboratory—interdisciplinary research groups funded initially through Dennis and Joan Gillings’ transforming gift to the School of Public Health announced in February. The center will also seek funding from groups including the National Institutes of Health and from industry.
“Tens of thousands of patients participate in clinical trials each year, and their experiences benefit essentially everyone. New methods, integrated into practice more quickly, would make this powerful tool even more effective,” said Julie MacMillan, director of Carolina Public Health Solutions, the program within the School of Public Health that will administer initiatives driven by the $50 million Gillings gift. “Dr. Ibrahim is an international expert in new statistical methods and a strong leader who can bring together perspectives from many disciplines to truly advance the science behind clinical trials.”
By Hope Baptiste
