Calling out clinical trials as the “most expensive part of drug discovery and development,” Acting U.S. Food and Drug Administration (FDA) Commissioner Dr. Ned Sharpless just told agency staff he’s committed to promoting the use of innovative trial design among other tools to improve efficiency and speed delivery of drugs and devices to market.
“We will continue to promote…platform trials, basket studies, adaptive trials, and pragmatic randomized controlled trials that are more efficient and will lower costs of running trials,” Sharpless said in an all-staff email dated July 23. Sharpless was named acting chairman of the FDA after Dr. Scott Gottlieb announced he was stepping down earlier this year.
Sharpless took the opportunity to praise real-world evidence [RWE] in clinical trials. “We will also continue to promote [it], both for pre- and post- market adverse event detection as well as for efficacy analysis for clinical situations where randomized clinical trials may not be feasible,” he told FDA staff. “Enhanced used of [RWE] for regulatory decision making will improve the generalizability of evidence to patient populations that me be excluded from traditional clinical trials,” he added.
Sharpless also said the agency would continue to use “novel approach pathways” for drugs, biologics, and devices approvals.
The acting director told his team that the agency was going to invest in new technologies and new personnel in the coming months. “We need to recruit, develop, and retain world-class people, and will be announcing more specific plans in these areas soon,” Sharpless said.
“To support cutting edge regulatory frameworks, we are investing in the development of modern and more integrated IT systems and advanced analytics to help our reviewers, managers, and investigators perform their duties more efficiently,” he said. “This includes greater use of real-world and, in some cases, even real-time data to strengthen our ability to regulate innovative products effectively through the product life-cycle,” he added.
Author: Michael Causey