Webinar: Learn About FDA Waivers for TQT Studies: How Early Precision QT™ for Cardiac Safety Testing Can Elevate Drug Development and Lower Study Costs

A drug's propensity to cause QT prolongation has to be carefully evaluated in the course of clinical development, and until recently, regulators have required a designated study, the thorough QT (TQT) study, to rule out a small QT effect. It has however become increasingly clear that the TQT study is overly sensitive and results in a number of false positives, i.e. drugs that are labelled as causing clinically relevant QT prolongation based on a very small effect, which is unlikely to be proarrhythmic.

Exposure response analysis has emerged as an important way to predict drug-induced QT effects in patients and have been widely applied to data from TQT studies. More recently, a collaborative initiative was undertaken between industry, the Cardiac Safety Research Consortium and FDA, to prospectively evaluate whether exposure response analysis applied to data from early clinical trials using intense ECG monitoring with a High Precision QT technique can detect the QT effect of a group of known QT prolonging drugs. The objective was to demonstrate that this approach can exclude small QT effects with the same confidence as in TQT studies and thereby serve as a replacement. The IQ-CSRC study was fully successful and has led to the decision by the ICH E14 group to revise the clinical guidance document.

The purpose of this webinar is to share the results of the IQ-CSRC study, discuss best practices for collection of high precision ECG data at the site, discuss what it will take to obtain a waiver for the TQT study and to which extent there is a remaining role for TQT studies.

Learn more here: http://xtalks.com/FDA-Waivers-for-TQT-Studies.ashx