The historical approach to assessing a drug’s effect on cardiac repolarization involved conducting a costly Thorough QT (TQT) study. The guideline revision adopted in late 2015 allows the possibility to obtain reliable ECG data from early stage studies by leveraging high precision QT analysis and exposure-response modelling. Sponsors can benefit from significant cost savings and evaluate the cardiac safety of their compounds earlier in their development strategy.
In addition to numerous trials with intense ECG monitoring, High Point Clinical Trials Center research staff have undergone extensive training ensuring that highly precise cardiac safety data is obtained from First in Human Studies and other early stage Studies.
“Evaluation of a drug’s potential effect on the QT interval can be generated with high confidence using exposure–response analysis of electrocardiogram and pharmacokinetic data from first-in-human studies.”
“iCardiac Technologies, Inc. in the fall completed a study in collaboration with the U.S. Food and Drug Administration that demonstrated cardiac toxicity in drugs can be detected much earlier in the development process than previously thought by medical professionals.”