If you are in clinical development and interested in latest developments in cardiac safety blood pressure (BP) requirements, I encourage you to attend a public workshop announced by the U.S. Food and Drug Administration (FDA) entitled "Evaluating the Pressor Effects of Drugs & Ambulatory Blood Pressure Monitoring Studies." This workshop is convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with the FDA. The purpose is to bring the stakeholder community together to discuss the premarketing assessment of a drug's effect on blood pressure. Elevated blood pressure is known to increase the risk of stroke, heart attack, and death. The effect of a drug on blood pressure may therefore be an important consideration in benefit-risk assessment.
According to the agenda, the day's discussion will be built around key questions and considerations established in the agency's recently released FDA draft guidance for industry on the Assessment of Pressor Effects of Drugs. Experts in blood pressure research and ambulatory blood pressure monitoring measurement from the regulatory, academic, and drug development communities will be convening to discuss the premarketing assessment of a drug's effect on blood pressure. The FDA indicates it is specificically interested in soliciting feedback regarding four high-priority topics:
- Understanding the temporal relationship between changes in blood pressure and changes in risk.
- Interpreting results of the PRECISION study and its relevance to the pressor guidance.
- Is there a BP increase of concern applicable across development programs or should each development program take its risk tolerance into consideration? What is the role of the patient population?
- The necessity of using placebo groups as controls in ABPM studies.
The public workshop takes place in Washington, DC, on February 4, 2019, from 9:30 AM-4:30 PM. Attendance may be in-person or via webcast. Visit the Duke-Margolis registration webpage for more details and to register.
This is an opportunity to hear directly from the regulators, industry and academic community regarding the implementation of the new cardiac safety BP guidance.
I will be attending the workshop in-person. If you’d like to connect there or another time, drop me a line. Until then, I invite you to explore more on the topic in my recent blog post: Preparing for Upcoming FDA Guidance on Blood Pressure (BP) Response in Clinical Trials.
For assistance with BP and cardiac safety in clinical trials, please reach out to me anytime via email at Jeff.Helibraun@bioclinica.com.