Top US FDA officials have made no secret about their desire to see sponsors more frequently use adaptive clinical trial designs, and Center for Drug Evaluation and Research (CDER) Director Janet Woodcock has tapped the ongoing I-SPY 2 trial as a model for their more broad uptake in the future.
"I-SPY 2 is an innovator," Woodcock said Sept. 12 at the National Press Club. "It's way ahead of the game