The two new guidances provide recommendations on clinical trial design considerations for Phase II and III studies, and aim to help drug developers get to the investigational new drug application (IND) stage.
In this guidance, the US Food and Drug Administration (FDA) outlines recommendations for establishing the safety and efficacy of therapeutic medicines for COVID-19 through phase II and III clinical trials. It is focused on antiviral drugs or drugs with immunomodulatory activity. The guidance does not apply to vaccines or convalescent plasma.
The guidance considers study population, trial design, efficacy endpoints, safety and statistical considerations. It is strongly recommended that COVID-19 drugs are evaluated in randomised, double blind trials with a superiority design. Clinical outcomes should include all-cause mortality, respiratory failure, need for invasive mechanical ventilation and sustained clinical recovery.
This guidance aids navigation of the pre-IND process, to enable drug and biologic developers get their products into clinical trials more efficiently. During this pandemic, the FDA’s pre-IND meeting request and package development process have been combined into a single step. Requests will be prioritised based on completeness of submission and scientific merit.
The guidance provides recommendations on the content of pre-IND meeting request submissions, non-clinical, clinical and quality considerations, and additional recommendations for antiviral and inhalation drugs.
“Accelerating the investigation of safe and effective therapies that could benefit people affected by the COVID-19 pandemic is one of the FDA’s highest priorities. We are committed to maximising our regulatory flexibility and using every tool at our disposal to speed the development and availability of these medical products and believe these new guidances will help innovators and researchers do just that.”