Over the past few years, the number of new cancer drugs approved by FDA has been dwindling. Critics generally cite exorbitant costs, lack of accrual to trials, conflicts of interest, and government regulations as the primary reasons for the dearth of new molecular compounds.
According to a new study group from the University of North Carolina, Chapel Hill, School of Public Health, our clinical trial system itself diminishes our ability to make safe and effective drugs available to the public in a timely manner.
Led by Joseph G. Ibrahim, PhD, the UNC Center for Innovative Clinical Trials has an interdisciplinary focus and theme involving several departments at UNC as well as collaborators from other institutions. The Center received initial start-up funding through a gift from Dennis and Joan Gillings to the School of Public Health.
A primary focus of the Center is to advance statistical science in clinical trials and move that knowledge into clinical and statistical practice. "Our goal is to become globally recognized as the premier leader in research regarding clinical trials," Dr. Ibrahim told ONI.
The structure of the initiative is a multipronged approach of methodological research (see Table on page 27), applied interdisciplinary research, outreach to industry, education, and critical evaluation of clinical trial methods, he said.
"The Center is unique in that we are developing new statistical methods for clinical trials, " said Dr. Ibrahim, who is also Alumni Distinguished Professor of Biostatistics and director of the biostatistics core at the Lineberger Comprehensive Cancer Center.
Dr. Ibrahim said that phase III clinical trials require a multidimensional approach in which several endpoints are examined simultaneously. "We think this will make adverse events, toxicity, treatment interventions, and quality-of-life results more apparent earlier on in the conduct of the trials," he said.