• The FDA should allow developers to perform the more advanced preclinical (animal) studies at the same time as Phase 1 clinical trials, which are performed in a small number of healthy subjects.
• Lower to 10 days the usual 30-day waiting period from the time the application is submitted to the FDA to the start of the Phase 1 trials.
• In collaboration with experienced vaccine developers, the FDA should publish a template “master protocol” for streamlined Covid-19 vaccine development. Trials should have an “adaptive” design: If one vaccine candidate is found not to work, investigators can quickly move on to testing the next most promising one without delay.
• “Unblind”—that is, review—the results early in the clinical trials so researchers can be aware of obvious positive or negative findings sooner.
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