Cardiac Safety Assessments In Clinical Trials

Understanding cardiac safety early in development can be the difference between advancing a promising therapy and facing costly delays. This issue explores the evolving role of electrocardiography (ECG) and QT interval assessment in clinical trials, highlighting how modern cardiac monitoring strategies are helping sponsors evaluate risk with greater precision and efficiency.

From a practical ECG primer to an overview of global regulatory expectations under ICH guidance, readers gain valuable insight into why QT/QTc assessment remains a cornerstone of drug development. Key considerations around study design, timing, and emerging concentration-response modeling approaches demonstrate how cardiac safety evaluations can be integrated earlier in clinical programs to support informed decision-making. The issue also features a Phase I case study involving a novel cannabis formulation, where advanced ECG monitoring techniques were used to assess cardiac effects across multiple dosing regimens in healthy volunteers.

Learn how innovative methodologies are reshaping cardiac safety assessment while supporting regulatory confidence and protecting participant safety