Full Extent Of Clinical Trial Damage May Be Unknown Until Pandemic Ends, CBER’s Peter Marks Says
More patient-centric trial designs also may be coming due to pandemic-related advances, Marks says.
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Among hundreds of trials underway on potential therapeutics, only about 6% of study arms are expected to yield actionable data because most are nonrandomized, underpowered or underenrolled, Operation Warp Speed’s Janet Woodcock says, renewing her pitch for adoption of master protocols and other approaches to streamline studies and improve efficiency.
Both sides want enhancements to deal with growth in cell and gene therapy, as well as work on regulatory decision tools and finance issues.
Multiple stakeholders call for CBER to receive more prescription drug user fee funds amid growing cell and gene therapy popularity.