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PhinC, Phaster 1 and Cardiabase set up an innovative design for TQT studies

This innovative TQT study design will be tested on November 2014. Follow PhinC Development News to discover step by step the results of this TQT study.

PhinC Development, and its partners Cardiabase and Phaster 1, are pleased to announce the setup of an innovative design in TQT trials concerned by the ICH E14 guideline. This design, supported by original statistical evaluation, aims to make clinical trial easier to conduct, more economical but as conclusive as the traditional design (QT regulatory). PhinC and its partners launch together a first study using this innovative method that was submitted to Health Authorities on September and planned to start on early November. We will communicate a feedback about this study in early 2015 when complete analysis will be finished.

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Reminder about QT studies : In 2005, Health Authorities, through the ICH-E14 guideline, made cardiac safety a compulsory requirement for drug development, even for non cardiovascular drugs. Indeed, it has been demonstrated that drugs can provoke a QT prolongation which is an early warning sign of torsade de pointes (TdP) potentially leading to death. The mandatory studies are called “thorough QT/QTc study” (TQT). They include heavy electrocardiogram (ECG) monitoring and data management, and require a high level of expertise in design of studies, analysis and interpretation of results.

 

For more information about TQT PhinC services : Click here.