Standardized and centralized blood pressure monitoring in clinical trials has expanded from a preliminary focus in cardiovascular, specifically hypertension drug development, as an efficacy endpoint to an increasingly important safety endpoint across all therapeutic indications. The development of the draft FDA pressor effect guidance evolved out of industry and regulatory discussions with the goal of enhancing patient safety.
One of the primary goals of this session is to provide insight and clarification associated with the draft guidance. Although a well-recognized diagnostic endpoint in clinical care and drug development, blood pressure assessment continues to be an important topic of discussion in drug development. This presentation will focus on the implementation of BP monitoring in clinical trials with specific attention to the considerations to monitoring blood pressure as a safety “Off-target” endpoint
What you will learn: