Experts in preclinical and clinical ECG safety assessment discuss how advances in arrhythmia detection and concentration effects modelling improve study outcomes.
Comprehensive assessment of ECG intervals and arrhythmias is now practical in both preclinical and clinical research studies. A subset of the available information is currently required by the FDA, and researchers are challenged to balance the value of knowing more against potential liabilities of evaluating and submitting incremental data.
During this webinar, experts review advances in ECG safety assessment including reductions in interval measurement variability, reductions in confidence limits in concentration effect models and accurate reporting of up to 20 common arrhythmias.
The clinical perspective is delivered by Dr. Jay W. Mason. He discusses reductions in interval measurement variability and confidence limits in concentration effect models and review the implications for clinical TQT studies and Phase I (IQ-CSRC) studies supporting TQT waivers, stressing why tighter confidence limits and more accurate measurements matter.
Following, Mike Gralinski, CEO of CorDynamics, offers a preclinical perspective on the potential of incorporating detailed assessment of arrhythmias for every cardiovascular study, and shares his thoughts on how and when this additional information should be leveraged. He discusses the value of knowledge versus liability of disclosure, the potential value of pre-study arrhythmia screening and incorporating baseline/control arrhythmia assessment.
Key topics covered during this webinar include:
- Opportunities to improve FDA acceptance of phase I (IQ-CSRC) studies in support of TQT waivers.
- How and when comprehensive arrhythmia assessment should be leveraged in preclinical safety assessment.
- Why accurate interval measurements and tighter confidence limits matter.