Cardiac safety issues are among the most common reasons

for promising drugs being halted in development and not

brought to market. The ICH E14 Guidance for Industry

requires every new drug to be tested for QT prolongation

to predict the risk of Torsades de Pointes (TdP), a lethal

arrhythmia. However, sponsors who rely on site-managed

ECGs may be risking data quality. There are significant

differences between site-managed and centralised ECG

data collection and analysis. Ellen Street, Executive Vice

President, Cardiac Safety at ERT, explains why it is critical

that sponsors understand how their selected method could

make the difference between success and failure as they

develop new medical products.