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 One of the primary goals of this session is to provide insight and clarification associated with the draft guidance.
TORONTO (PRWEB) April 15, 2021
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. 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 One of the primary goals of this session is to provide insight and clarification associated with the draft guidance.
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. Previous discussions surrounding the topic re-surfaced in early 2000 and have continued to be an important industry consideration as noted in recent industry and scientific presentation and publications. Included in the webinar will be a review of the BP monitoring options that have been implemented in clinical trials including: Ambulatory Blood Pressure Monitoring (ABPM), Automated Office Blood Pressure Monitoring (AOBPM) and remote telemonitored home blood pressure (BP).
Register for this session to hear a review of trial design considerations and technology/BP methodology selection using a case study approach.
For more information, or to register for this event, visit Blood Pressure Monitoring in Clinical Trials: A Sponsor and Site Perspective.
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