The University of Cincinnati, Case Western Reserve University and Ohio State University began collaborative efforts in August with the intent of increasing the pace for approval of shared clinical trials.
The new system should cut approval times from two to three months to about two weeks, said Dr. Carl Fichtenbaum, the assistant dean at UC’s College of Medicine. The beauty of the system is that it only requires the approval of one institution instead of every participant, Fichtenbaum said.
The new plan has already shown its effectiveness at UC, Fichtenbaum said. He has been researching infectious diseases for 13 years.
“I’m glad it’s working for the study I’m working on,” Fichtenbaum said. “I can’t see a negative.” The university’s involvement in the new plan came at the suggestion of Susan Groh, manager of Regulatory Affairs for UC’s AIDS Clinical Trials Unit, Fichtenbaum said.
“[Groh] thought it would be a great idea if we used the review board of Case Western,” Fichtenbaum said. “The effort was initiated by the colleges, I just happened to be the first to use it.” Groh was unable to respond to interview requests.
Efforts are being made across Ohio to increase the pace of clinical study approval and attract out of state medical research investments, said Gov. John Kasich in the State of the State Address on August 7.
“You see, we’re working now to make a medical corridor,” Kasich said. “And what we know is if we get them to work together, we can have an awesome result in all the fields of medicine today and bring tremendous advancement to us. Divided we fall, work together we win.”
In Ohio, biopharmaceutical companies invested $734.6 million in research and development, and there were 2,906 ongoing clinical trials across the state in 2008, according to a 2008 report by Archstone Consulting, now a division of The Hackett Group.