RL24 Planning for Effective Use of QTc Data in Early Clinical Trials
*Mike Hale, Amgen 


Early clinical studies often collect QTc data which may be used for ongoing safety evaluation, supporting dose escalation decisions, exploration of a drug concentration relationship to QTc, to inform future trials, and possibly for meta-analysis as studies accumulate. To enable those possible uses requires attention in study design, conduct, and analysis. Some considerations include central (usually manual) versus local (usually machine) reading, correction methods, timing of measurements and replication, relative timing of pk samples, handling of baseline data, appropriate controls, data collection forms versus machine data files, specialty ECG vendors, covariate exploration, and statistical diagnostics. At this roundtable we’ll discuss implications of various choices, including estimation and inference possibilities, costs, study complexity, future studies, and regulatory interactions.