FDA launched a pilot program to collect and review clinical trial data in real time, giving scientific reviewers access to data as it flows in. AstraZeneca and Amgen are the initial pharma partners in the program focused on cancer drugs.
Real-time data access could compress the traditional months-long gap between trial completion and FDA review. The pilot scope remains narrow with just two sponsors, suggesting cautious regulatory approach to workflow changes.
Clinical operations leaders should track this pilot's impact on submission timelines and data requirements. Contact your FDA liaison to understand how real-time data sharing might affect your current trial protocols.