In May of 2018, the FDA issued draft guidance advising sponsors on assessing a drug’s effect on blood pressure during a clinical trial. Clarified further in 2019, this guidance is the result of regulators looking for a connection between blood pressure and cardiovascular events during drug therapy.
According to the FDA, ambulatory blood pressure monitoring (ABPM) assessment is the best way to describe blood pressure effects over a period of 24 hours.
To learn more about this FDA guidance, ABPM, and blood pressure monitoring best practices, please join us on July 18.
Key takeaways from this webinar:
- Understand the FDA Guidance for blood pressure
- Discuss how to implement ABPM in your trials
- Uncover best practices and considerations for monitoring blood pressure