FDA Welcomes Variety of Phase 2/3 Trial Designs for COVID-19 Therapies
Summary
At the same time, however, the agency seeks rigorous clinical evaluations that meet traditional regulatory standards, ideally with placebo controls, randomization and double blinding. The mechanism of action of a drug candidate influences important study design elements, ranging from population and endpoints to safety assessment and duration of follow-up, the guidance notes. The COVID-19 pipeline is notable for its variety of approaches, ranging from products attacking viral replication and entry to neutralizing antibodies to anti-inflammation agents, immunomodulators, stem cells and RNA interference. Clinical trial sites also should include “geographic locations with a higher concentration of racial and ethnic minorities to recruit a diverse study population.” At the same time, the document notes, “given the expected fluctuation in regions in the frequency of SARS-CoV-2 infection, sponsors should address the need to open new sites and potentially suspend existing sites.” “Children should not be categorically excluded from clinical trials of investigational COVID-19 products in which there is a prospect for direct benefit,” the guidance states. “Everyone agrees a master protocol structure where you are testing multiple therapies simultaneously is probably the only way to do this efficiently and where you can add or drop arms as they succeed or fail,” David Wooley, senior VP of research partnerships at the Foundation of the National Institutes of Health, said.
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