Testing, Testing, (Phase) 1-2-3: Legal Considerations for Clinical Trials of Potential COVID-19 Vaccines

"In the race to develop a Coronavirus Disease 2019 (COVID-19) vaccine, several pharmaceutical companies, governments, and educational institutions around the world have begun testing their potential COVID-19 vaccines in clinical trials. Clinical trials are used to assess whether a new pharmaceutical product, such as a vaccine, is safe for humans and effective in achieving its intended purpose. Companies must generally test new pharmaceutical products on humans through clinical trials to obtain U.S. Food and Drug Administration (FDA) approval to market the product. But using human subjects to test these novel products exposes them to unknown health and safety risks, raising ethical considerations for FDA and for the sponsors and Institutional Review Boards (IRBs) overseeing the investigations. These stakeholders—sponsors, IRBs, and FDA—aim to balance the need to ensure that the product is safe and effective against the desire to bring the product to market quickly, tensions that are heightened during a worldwide pandemic. Existing law requires FDA and IRBs to weigh these considerations when evaluating proposed clinical trial designs for COVID-19 vaccines.

This Sidebar describes the legal and regulatory framework that governs clinical trials for pharmaceutical products, such as vaccines, and some avenues researchers and Congress may consider for accelerating that process during the COVID-19 pandemic. (For ease of reference, this Sidebar uses the term drugs includes both traditional drugs and biological products, including vaccines.).."
Testing and clinical trails

FDA issues final rule on safety information during clinical trials
"The U.S. Food and Drug Administration today issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics.

“This final rule will expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics,” said Rachel Behrman, M.D, associate director for medical policy in the FDA’s Center for Drug Evaluation and Research. “These changes will better protect people who are enrolled in clinical trials.”

The new rule requires that certain safety information that previously had not been required to be reported to FDA be reported within 15 days of becoming aware of an occurrence. These reports include:

findings from clinical or epidemiological studies that suggest a significant risk to study participants

serious suspected adverse reactions that occur at a rate higher than expected

serious adverse events from bioavailability studies which determine what percentage and at what rate drug is absorbed by the bloodstream and bioequivalence studies which determine whether a generic drug has the same bioavailability as the brand name drug.."