FDA Draft Guidance Blood Pressure Monitoring In Clinical Trials

By Jeff Heilbraun, MS – VP Medical Affairs, Cardiac Safety

In the realm of clinical trials, blood pressure monitoring holds significant importance. It finds mention in protocols across all study phases and therapeutic indications, primarily due to its association with the study's schedule of events as a standard vital sign or safety assessment.

To better focus on the “off-target” effect (increase) in blood pressure of all therapeutic agents in development, in 2018 the FDA released a draft Pressor Effect guidance. For a few years, the draft was submitted for public review and discussion until an update to the draft guidance was released in February 2022. In the months that followed, the cardiac safety team at Clario provided an overview of the updated draft guidance in a webinar, which can be found through the following link.

Based on the webinar, readers can review expert responses to questions that were compiled and answered regarding the FDA’s draft Pressor Effect guidance. Specifically, readers of the Q&A will learn how the guidance will affect drug development studies, as well as general considerations of blood pressure monitoring within the clinical trials arena, including developing technologies and additional hemodynamic endpoints outside of traditional brachial BP values.