Article | May 16, 2017

Are You Prepared To Replace The Thorough QT Study?

Source: ERT

Robert Kleiman, MD, Chief Medical Officer and Vice President, Global Cardiology, ERT


Regulatory bodies have adopted the 2005 ICH E14 guidance to mandate the evaluation of a new drug’s effect on QTc in a formal Thorough QT (TQT) trial for cardiac safety issues. The updated release to the ICH E14 Guidance could indicate that data be used to replace a TQT trial for regulatory submission and review. Learn more about how planning ahead can save time and money later for some clinical trials.