Speedy validation sought for new cardiotoxicity testing strategy

Kelly Rae Chi

Nature Reviews Drug Discovery volume 12, page 655 (2013)Cite this article

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Current regulations include non-clinical and clinical tests — namely, the measurement of electrical current through the HERG (also known as KCNH2) potassium channel, an in vivo QT assay in an animal model and a trial examining the drug's effects on healthy volunteers' QT interval (a thorough QT study). Attendees of the meeting — 180 stakeholders from industry, regulatory agencies and academia — largely agreed that, because this current paradigm is costly and leads to false positives, a new approach could be more useful and predictive.

But whether the two proposed approaches should replace the current requirements, particularly the thorough QT study, was a point of debate in the meeting — at which many attendees were hearing about the assays for the first time. Their acceptance, of course, hinges on how well they perform in validation studies. But one message was clear: the industry is not ready to rely solely on these proposed approaches anytime soon.