Woodcock Warns Research Apparatus Could Be Overwhelmed If Coronavirus Trials Don’t Use Master Protocols
CDER Director Janet Woodcock says researchers need to embrace pragmatic trial designs and compare multiple treatments at the same time rather than employ separate development programs.
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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.
COVID-19 has helped demonstrate the viability of platform trials with a shared control arm. That model is easier to extol than it is for sponsors to embrace, especially outside of crisis mode.
BIO 2020 Notebook: FDA's Hahn On COVID-19 Lessons To Be Learned; NIH's Fauci On Health Care Disparities; Pfizer's Young On Forgoing Gov't Vaccine Funds
News and views from day three of BIO Digital. US FDA Commissioner Hahn asks industry to help identify best regulatory lessons from the pandemic; Pfizer’s chief business officer explains how need to move quickly in vaccine partnership with BioNTech led to decision to forgo US funding.