US Group Advocates Clinical Trials Update
Pointing to deaths in clinical drug trials every month since December 2015 worldwide, the US Center for Responsible Science (CRS), a nonprofit advocacy group pushing for “more modern and predictive” test methods in drug development, has renewed its call for the Food and Drug Administration (FDA) to update 29 regulations to allow the preclinical test method most predictive of human response is used during drug testing.
Under current FDA regulations, CRS said, serious adverse events are either not required to be reported in public databases (phase I) or are simply not reported as required (phase II and III); thus it is unknown how many deaths and other serious adverse events have occurred in US trials.
These regulations mandate the use of animal models, despite great progress in more human relevant tests, the organization says.
“With the recent documented failure of animal-based preclinical test methods to predict safety in humans, it is more urgent than ever that FDA update regulations to broaden drug sponsors’ options to use the most predictive tests available,” said CRS president, Neil Wilcox.
“More predictive test methods will better ensure the safety of volunteers and patients involved in clinical trials and beyond,” CRS said. “It is in the best interests of investigators, drug manufacturers, human trial subjects and American consumers that the IND and IDE regulations are modified as requested in this petition,” the group added.
