Blood Pressure Monitoring in Clinical Trials: A Sponsor and Site Perspective, Upcoming Webinar Hosted by Xtalks

Share Article

In this free webinar, the featured speaker will discuss the approach to defining an off-target increase in blood pressure for a developing compound and differentiate between the devices available for assessing BP in clinical trials. The presentation will highlight the identification of design and analysis considerations for a study to define the potential BP signal, and also provide case study experience in implementing BP monitoring in clinical trials across different trial phases.

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 One of the primary goals of this session is to provide insight and clarification associated with the draft guidance.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. 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 One of the primary goals of this session is to provide insight and clarification associated with the draft guidance.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.

Join Jeff Heilbraun, VP, Medical and Scientific Affairs, Cardiac Safety Service, Bioclinica, for the live webinar on Wednesday, May 5, 2021 at 11am EDT (4pm BST/UK).

For more information, or to register for this event, visit Blood Pressure Monitoring in Clinical Trials: A Sponsor and Site Perspective.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Ayesha Rashid
Xtalks
+1 (416) 977-6555 x 272
Email >
Visit website