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US FDA Welcomes Variety Of Phase II/III Trial Designs For COVID-19 Therapies, But With Standards

 
• By Bridget Silverman

Final guidance on COVID-19 treatment development emphasizes need for clinical endpoints to reflect drug mechanism, patient population, clinical setting and fast-evolving standard of care – with a cautious embrace of platform and adaptive designs.

Virus vaccine and flu or coronavirus medical fight disease control as a doctor fighting a group of contagious pathogen cells as health care for researching a cure with 3D illustration elements.

The US FDA’s formal guidance on development of COVID-19 treatments and preventative agents takes a broadly flexible approach to Phase II and III trial design, repeatedly indicating a willingness to consider varied options while urging sponsors to discuss their trials plans with the agency earlier rather than later.

“FDA is committed to supporting all scientifically sound approaches to attenuating the clinical impact of COVID-19,” the guidance declares

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