It has been nearly 10 years since the approval of the ICH E14 guidance, which described the requirements for a Thorough QT/QTc study (TQT) to assess a new drug’s liability for producing lethal ventricular arrhythmias. Since 2005, a TQT study has been required for all small molecule drugs which can safely be tested in healthy volunteers. Concerns have been raised, however, about the high cost of the TQT study and about the inhibitory effect that this guidance has had on drug development. Recently, two proposals for replacing the TQT have been discussed – one to replace the TQT with a series of preclinical studies, and the second to replace the TQT with intense ECG and PK data collected during Phase I ascending dose studies.
A meeting was held on Dec 11-12, 2014 by the Cardiac Safety Research Consortium and the FDA to discuss these two proposals and to present the results of a prospective trial to test the feasibility of using Phase I ascending dose data to replace the TQT. The webinar will discuss the results of this new study, progress towards developing alternative pathways to the standard TQT, and the changing regulatory environment for cardiac safety in drug development.
Event Details Available Here.