Clinical trial sponsors need actionable and reliable information about the cardiac safety profiles of their compounds as soon as possible during drug development. So why haven’t more sponsors embraced the option from 2015 ICH E14 guidance, which enables them to conduct ECG analysis during routine Phase I studies and benefit from this early knowledge?
By conducting Phase I ECG assessments, sponsors can characterize the QT effect of their compounds early – and with less likelihood of inconclusive or false negative results than traditional safety ECG assessments – to gain greater confidence in compound safety and the success of their development programs.
This early insight can be leveraged in other ways, too. Sponsors conducting Phase I ECG testing can:
- Better prioritize their drug development pipelines
- Make go/no-go decisions sooner
- Appropriately resource or refocus programs exhibiting potential cardiac safety issues
Simply stated, early phase QT assessment enables sponsors to invest their resources only on potentially viable compounds instead of wasting time continuing to develop therapies that might later prove to be unsafe or otherwise not viable.
Also, determining a compound’s cardiac safety profile early enables researchers to leverage this information in discussions with investors or partners. Doing so can add significant value to drug candidates, which ultimately impacts licensing or other business development activities.
Lastly, there are significant efficiency improvements that early QT testing offers. By conducting cardiac safety testing during routine Phase I trials, sponsors can eliminate the millions of dollars typically invested in a separate, designated TQT study later in development.
Cardiac safety issues are among the most common reasons for promising drugs to be halted in development and failing to launch, so waiting to see if there’s a potential problem just doesn’t make sense. Clinical trial sponsors who conduct QT assessments during Phase I can harness the power of this early knowledge to better inform their development decisions while saving considerable time and money.
Click here to download ‘Implications of the IQ-CSRC Prospective Study: Time to Revise ICH’ and discover how ERT’s Early Precision (EPQT) methodology provides a reliable alternative to costly, standalone TQT studies.
Dr. Borje Darpo is the Chief Scientific Officer of Cardiac Safety at ERT