Adaptive Trial Designs Need Elaborate Firewalls To Prevent Data "Leakage," US FDA Says
Sponsors should realize that only a very few people – think 4, not 50 – will be permitted to be unblinded, CDER's Laura Lee Johnson tells the DIA annual meeting.
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US FDA says sponsors generally won’t need to publicly disclose company or product if selected for pilot, but rather elements about design of their complex trial.
Discussions through the WHO are aimed at educating low- and middle-income countries, while efforts with ‘the larger regulators’ aim to reduce the development burden for products targeting ultra-rare diseases, CBER director Peter Marks tell DIA.
Acknowledging the toll that vaccine opponents have taken on FDA operations, the CBER director emphasizes the need to create stand-by manufacturing capacity, conduct faster studies in special populations, and better understand the mRNA platform.