Minimized COVID-19 Impact on Phase 3 Trial

A client was conducting their Phase 3 program in over 400 centers and 37 countries when the COVID-19 Pandemic hit. Dr. Gorelick was tasked with developing a strategy to keep the program going while keeping patients and caregivers safe. As the FDA had previously denied a request for home administration of the parenteral agent, Dr. Gorelick proposed that this could be a potential consideration to ensure patient access to treatment in the context of COVID-19. Together with the Clinical Operations and Pharmaceutical Development teams, he developed a home administration program, crafted a request to FDA, and with FDA’s telephonic support initiated a program that resulted in minimal patients missing doses and/or dropping out while clinical sites were closed due to the pandemic.