In this free webinar, learn about potential upcoming changes for cardiac safety requirements for CNS and chronically administered drugs. The speakers will take a closer look at the regulatory, scientific and technological evolutions in blood pressure and how these have impacted clinical trial design. The strengths and challenges of blood pressure modalities will be assessed for various study types, with a focus on Ambulatory Blood Pressure Monitoring (ABPM) per the draft guidance.
TORONTO, Ontario, Canada, April 28, 2023 /PRNewswire-PRWeb/ -- Drugs that are chronically administered, such as those for CNS disease states, are under increased scrutiny for potential effects on cardiac safety endpoints, and for good reason. Whereas a small change in blood pressure may be inconsequential for drugs administered over a short timeframe, the story is very different for drugs that are likely to be taken for years or decades. Prolonged changes in blood pressure or QT interval are associated with a variety of patient health risks and prescribers need to carefully weigh the risks and benefits. Regulatory agencies understand this challenge and have drafted recent guidance to better detect even small changes in cardiac safety, ensuring that a drug's risk profile is well-established during development, with increased attention given to chronically administered drugs.
Further changes are coming to clinical trials, and drug developers need to be prepared to think about the cardiac safety of their drugs, beyond just QT/ECG evaluation. While blood pressure has long been a part of safety endpoints for select drugs with known risk, there has not been a formal guidance in place. In February of 2022, the US Food and Drug Administration (FDA) issued their draft Pressor Effect Guidance, with a particular focus on chronic-use drugs. The draft guidance also looked at common modalities for blood pressure collection, highlighting the advantages of Ambulatory Blood Pressure Monitoring (ABPM).
For long-term CNS drugs, blood pressure evaluation has become a critical consideration to establish the potential risk for stroke or other cardiovascular diseases.
Join featured experts from Clario as they discuss the cardiac safety requirements (BP & ECG) for CNS and chronically administered drugs. The speakers will then take a closer look at the regulatory, scientific and technological evolutions in blood pressure and how these have impacted clinical trial design. The strengths and challenges of blood pressure modalities will be assessed for various study types, with a focus on ABPM per the draft guidance.
Sign up early to get any questions in the queue for the experts!
Join Dr. Robert Kleiman, MD, Vice President & Chief Medical Officer, Cardiology, Clario; and Jeff Heilbraun, MS, Vice President, Medical And Scientific Affairs, Cardiology, Clario, for the live webinar on Friday, May 19, 2023, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit CNS and Chronic Drug Trials: New Cardiac Safety Requirements.
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Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: [email protected]
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Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, [email protected]
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