The 2 new guidance documents provide sponsors with clear direction on data required for IND application and on the structure of phase 2 and 3 clinical trials.
The FDA on Monday evening issued 2 new guidances intended to help ramp up the development of medications to prevent or treat coronavirus disease (COVIC-19), according to an Agency press release.
The first details steps to help companies more rapidly reach the investigational new drug application (IND) stage; the second outlines clinical trial design, including important clinical outcome measures.
Pre-IND
The first guidance outlines a streamlined process for developers to receive agency feedback on their supporting data with the goal of starting clinical trials as soon as possible. The guidance clarifies the types of data FDA will look for that will address clinical, nonclinical, and quality considerations before submitting IND application.
“It is essential that the Agency receive key information that will help enable us to efficiently address proposals and ensure they are properly evaluated and managed in a timely manner.FDA is issuing this guidance to facilitate a sponsor’s preparation of, and FDA’s review of, a pre-IND meeting request. Well-prepared pre-IND meeting requests should enable more timely initiation of clinical trials under an IND,” reads a portion of this guidance.
Clinical guidance
The second guidance provides the Agency’s current recommendations on phase 2 and phase 3 clicnial trials to establish safety and efficacy of therapeutic and prophylactic agents for COVID-19.
The guidance focuses on development of direct antiviral drugs or products with immunomodulatory activity and notes that the guidance does not apply to preventative vaccines or convalescent plasma.
Treatment trials: Essential clinical outcome measures
Prevention trials: Primary endpoint
“FDA anticipates this guidance will help sponsors to efficiently design studies that may lead to the review and potential approval of safe and effective drugs and biological products to address the COVID-19 pandemic,” states FDA's document.
The guidance provides specific recommendations for study population, trial design, efficacy endpoints, safety, and statistical considerations.
FDA says it “strongly recommends that drugs to treat or prevent COVID-19 be evaluated in randomized, placebo-controlled, double-blind clinical trials using a superiority design,” and that standard of care should be applied in all treatment arms.
“Sponsors should address anticipated off-label use of any other drugs, devices, or interventions that might be used to manage COVID-19,” FDA writes.
The new guidance follows the launch of FDA’s coronavirus treatment acceleration program (CTAP) in March and the National Institutes of Health’s (NIH) Accelerating Covid-19 Therapeutic Innovations and Vaccines (ACTIV) public-private partnership in April.
As of Monday, FDA said there are 144 active clinical trials of therapeutics for Covid-19 and that it is aware of more than 450 development programs that are still in planning stages.
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