TQT Waivers: One Year Later

Overcoming Design Challenges

ICH E14 REGULATORY GUIDANCE 2005 AND 2015

It has been one year since the International Conference on Harmonisation (ICH) rp_Covance-Labs-Safety-Pills-300x200.jpgupdated its 2005 cardiac safety guidelines. The 2015 update allows for specific QT interval analysis based upon concentration effect modeling up to supratherapeutic during Phase I as a reasonable substitute for a Thorough-QT (TQT) dedicated trial.  These Phase I data along with preclinical results are submitted to the FDA prior to Phase III as a waiver request from a separate TQT study. This is good news! A dedicated TQT study involving time-wise comparisons of baseline corrected data is an expensive and lengthy endeavor. It typically takes place after proof of concept but before Phase III. Collection of QT information during an existing Phase I study costs substantially less and can provide go/no-go decisions much earlier. Continue reading