The U.S. Food and Drug Administration (FDA) this week moved to further development of prevention and treatment options for COVID-19 by providing new guidance with recommendations for innovators and researchers.
The FDA previously launched the Coronavirus Treatment Acceleration Program to help push new medical products to patients as quickly as possible, while weighing their efficacy and benefits against the risks. These new guidance documents further efficiency efforts and outline recommendations for ways to craft clinical trials as a means of evaluating the safety and effectiveness of medical products.
“Our staff continues to work around the clock with the world’s best innovators and researchers to help expedite the development of prevention and treatment options for COVID-19,” FDA Commissioner Stephen Hahn said. “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 maximizing 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.”
The first guidance, COVID-19 Public Health Emergency: General Considerations for Pre-IND (Investigational New Drug application) Meeting Requests for COVID-19 Related Drugs, laid out a process for developers to receive agency feedback on supporting data. This could help start clinical trials sooner. Further, it established FDA commitments to getting sponsors clarity on types of data and information they need to provide to address clinical, nonclinical, and quality considerations before submitting applications to begin studies.
The second, Biological Products and COVID-19: Developing Drugs and Biological Products for Treatment or Prevention, provided current recommendations on later-stage clinical trials meant to establish safety and effectiveness for COVID-19 products. It also outlined considerations sponsors should deem critical: appropriate patient selection and how to design trials — study duration, efficacy assessment, and how to monitor for safety — among them.