Moderating the panel, Mike Ranella asked Dr. Pipe about his first experience working with the CTSO on industry trials. “When the CTSO first opened, I was waiting at the door,” said Dr. Pipe. “When I saw how much work went into a Phase I, we began looking for a new infrastructure here at Michigan that would allow us to open more trials and make them available for patients. The timing on the development of the CTSO and the Children’s CTSU was really pivotal.”
“It’s funny that Dr. Pipe said he was waiting at the door because that is exactly how I feel like it happened,” said Nick. “The Children’s CTSU coordinator pool allows for cross-coverage in projects which is extremely important. Joining with Dr. Pipe’s team was not a takeover by any means. It was a complete collaboration.”
Dr. Pipe agreed, “these are high-regulatory-burden trials. First-in-man studies – seeing these patients every week. The amount of data we are collecting is massive. For Nick’s team to quickly build up that regulatory experience and to be able to execute was really important!”An emphasis was stressed by all panelists on the importance of having early success with industry partners. Fast activation, meeting recruitment goals, and a speedy, accurate administrative response impacts an investigator’s future opportunities to carry out industry studies.
Mike noted, “If it’s a predictable experience and there’s a high standard – industry highly values that and they’ll come back for more clinical trials in the future.”
The panel concluded that the CTSO’s infrastructure offers administrative and coordinator support freeing up a portion of an investigator’s time. Investigators can, in turn, direct more effort towards executing industry studies and recruitment allowing them to maximize benefits to their patients, develop innovative technologies, and build a more robust portfolio.