The clinical trials system is “broken,” according to the director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock.
The system needs new clinical trial networks and the adoption of master protocols – protocols for trials that focus on multiple therapies for a single disease or a single treatment that could apply to multiple diseases, Woodcock said, according to RAPS.
The director also reportedly addressed the use of real world evidence in determining effectiveness for drugs, cautioning that there has been “very little historical use of real world experience in drug regulatory decisions about effectiveness.”
Woodcock pointed out that real world evidence often offers strong support for a drug’s major effects, but can’t often support smaller effects.
Draft guidance on real world evidence and a framework outlining its use are slated to be released before 2021, according to Woodcock.
“Let’s make generating this evidence a lot easier and randomizing within the care system as much as we can,” Woodcock reportedly told the crowd at a workshop for the National Academies of Sciences, Engineering and Medicine.