FDA's drug center issues two key guidance documents tonight laying out more efficient path for pre-clinical, clinical studies for Covid therapeutics with emphasis on clinical trial efficiency, endpoints, efficient review paths fda.gov/regulatory-inf… and fda.gov/regulatory-inf…
These guidance documents, which address products from FDA's drug and biologics centers, are key effort by professional staff to lay out more predictable path for covid therapeutics with thoughtful guidance on trial endpoints, trial design. This will help advance development work.
FDA's professional staff and the Office of Policy have now issued close to 50 COVID-related guidances; all issued in the last two months. This is tremendous dedication and effort by the center professional staff and the team running the Office of Policy. fda.gov/emergency-prep…
These new drug review related guidances consolidated the review process, leveraged IND tools while EUA still remains an option, and identified relevant endpoints, study design considerations, and gave operational guidance to sponsors on what to submit and how to engage with FDA.
FDA recommends the use of platform trials such as a trial with a single master protocol in which multiple treatments are evaluated simultaneously as a way to improve efficiency; and the use of tools such as home based monitoring as a way to reduce risk of spread of infection. 
CDER/CBER say when there's compelling preclinical or preliminary clinical evidence of benefit, it may be appropriate to move directly into pivotal trial of sufficient size and design to provide substantial evidence of effectiveness and safety that could support approval.
The professional staff outline a range of clinical trial endpoints that can be considered in order to demonstrate substantial evidence of benefit and safety.
The agency breaks down some specific recommendations on the choice of time frame for measuring benefit, and acknowledges that the interpretation of endpoints may differ depending on the population evaluated in the trial. This kind of specificity will greatly help drug developers
A detailed explanation of how the agency defines moderate and severe illness should provide important clarity that will make clinical trial enrollment more predictable and efficient.
