Sponsors often set up a global trial that they run with different investigators “and then when the trial's done, they shut all that infrastructure down, and if you need another trial, it all starts up again, and so that wastes a lot of time, a lot of resources,” Woodcock said. “We have tried and are working on several master protocols that continuously run and can evaluate numerous investigational products at once, and many over time, because the trial doesn't shut down.”
“With vision and with persistence, we could develop a better trial system that could effectively and quickly evaluate therapies and really evaluate them dispassionately,” Woodcock said.
The agency is also working through the Clinical Trials Transformation Initiative (CTTI) “to bite off different pieces of the current trial conduct and design and re-design those, and I think we've made significant progress there,” Woodcock said.
The CTTI was established by Duke University and the FDA as a public-private partnership in 2007, and now comprises more than 60 member organizations working to identify and promote practices that will increase the quality and efficiency of clinical trials. Most recently the initiative unveiled recommendations to streamline Good Clinical Practice (GCP) training of investigators who participate in clinical trials.
Trial Funding Ethics
Woodcock also noted that another problem with trials, “at least in many people's mind, is that they are funded by the sponsor and conducted by people the sponsor pays.”
She calls instead for a more independent and non-biased way to conduct the trial and assess the data.
With master protocol-type designs, Woodcock said, “you have a trialist group, and they take money from many sponsors to evaluate their product, but they're more or less independent, because they're evaluating many different products, and this, to me, gives one degree of separation that would give a lot of people comfort about how…the data was generated and could be interpreted and relied upon.”