Pandemic Clinical Trials Need More Top-Down Control, Gottlieb Says
Ex-FDA commissioner offers British platform trials as examples of research done right, as he worries about studies that aren’t going to yield ‘definitive information’ crowding out trials that are more compelling and for more promising COVID-19 therapeutics.
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Decentralized and remote flexibilities should stay, Gottlieb says, but so should e-detailing efforts.
US government’s $450m manufacturing commitment for Regeneron’s antibody cocktail and Gilead’s price for remdesivir drive lower expectations on pricing for the antibody treatments, especially since it seems likely there could be several competing products.
Trump receives Regeneron’s experimental antibody under FDA’s expanded access program, Gilead’s remdesivir and dexamethasone. The president’s treatment choices could influence clinical trials of all COVID-19 medicines and even trial recruitment for other diseases, experts said.