In DepthDRUG DEVELOPMENT

A painstaking overhaul for cardiac safety testing

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Science  02 Sep 2016:
Vol. 353, Issue 6303, pp. 976-977
DOI: 10.1126/science.353.6303.976

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Summary

It's a crucial step in drug development: testing a compound to gauge whether it might cause cardiac arrhythmia. For years, researchers and drug developers have worried that standard preclinical tests for cardiac safety are actually too conservative, and may lead drugmakers to abandon promising and safe treatments early in development. Since 2013, an international team of regulators, academic researchers, and drug companies have been validating a more sophisticated set of tests, known as the Comprehensive in vitro Proarrhythmia Assay (CiPA). That painstaking process is inching toward completion. In the coming weeks, a key component of that assay, based on stem cell–derived heart cells, will undergo blind testing on drugs with known risks at various academic and industry labs, and the CiPA collaborators hope to propose a new set of testing standards by the end of next year.