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CHAPEL HILL – Seeking better ways to design and conduct clinical trials, the University of North Carolina at Chapel Hill School of Public Health has established a new 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.
“We want to find ways to speed up and improve the clinical trial process, and make it a more efficient, precise assessment of treatments, whether they are drugs, devices, or behavior modification programs,” said Joseph G. Ibrahim, Ph.D., Alumni Distinguished Professor of biostatistics in the UNC School of Public Health, and director of the biostatistics core at the Lineberger Comprehensive Cancer Center. “We want to find ways to 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. The ultimate goal is better healthcare.”
The center will have an interdisciplinary focus and theme, in which faculty from several departments at UNC as well as collaborators from industry and other universities will engage in both methodological and applied research in clinical trials design, analysis and evaluation. Members of the center will include faculty and other experts in biostatistics, statistics, medicine, epidemiology, maternal and child health, nutrition, environmental health, health policy, economics, business, dentistry, psychology, psychiatry, nursing, biology and chemistry.
The Center for Innovative Clinical Trials is the first Gillings Innovation Laboratory – interdisciplinary research groups funded initially through a gift to the UNC School of Public Health from Dennis and Joan Gillings. Dennis Gillings, a former professor at UNC, is founder and chief executive officer of Quintiles Transnational, a contract research organization based in the Triangle.
The center also will 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. “Joe Ibrahim is known throughout the world as an expert in new statistical methods. He’s also a strong leader who can bring together perspectives from many disciplines to truly advance the science behind clinical trials.”
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,” he 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 will 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 Gillings’ pledge, announced Feb. 21, raised total Carolina First commitments to more than $2 billion. The campaign, which supports UNC’s vision to become the nation’s leading public university, began July 1, 1999, and will end Dec. 31. Its public launch came in October 2002 with a $1.8 billion goal. That mark was raised to $2 billion in October 2005.