2023 - CNS and Chronic Drug Trials: New Cardiac Safety Requirements

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.
NODATA
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and challenges of blood pressure modalities will be assessed for various study types, with a focus on ABPM per the draft guidance.
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