During March 23-27, CTTI collected experiences from stakeholders across the clinical trials ecosystem – including insights on safety considerations, remote study visits, remote consent, consulting with IRBs, and more – related to the FDA’s new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. A recording of the March 31 webinar discussing those findings and best practices is now available.
Pam Tenaerts, CTTI, and M. Khair ElZarrad, FDA, CDER, opened the webinar by welcoming attendees and recognizing the importance of multi-stakeholder input and collaboration to move us forward during this crisis.
Sara Calvert, CTTI, then gave an overview on findings from CTTI’s recent effort to collect experiences and insights from across the clinical trials ecosystem, including best practices gleaned from participants around:
Colleen Rouse, Cleveland Clinic; David Borasky, WCG; and Cindy Geoghegan, individual patient representative/caregiver; provided unique perspectives and concrete examples related to these best practices. Among the many insights, the presenters unanimously underscorded that “ensuring the safety of trial participants is paramount” and communicating with patients is critical.
View a full slide deck from the webinar to read more from each presenter.