Strategy discussion of strengthening ECG monitoring in phase I clinical trials of investigational new drugs / 中国药学杂志

ABSTRACT

OBJECTIVE: To discuss the strategy of strengthening ECG monitoring in phase I study and to provide references for the necessity of thorough QT/QTc study and for the subsequent development strategies. METHODS: Relevant progresses in cardiac safety studies and guidelines of QT/QTc study were referred to in discussing the study strategy. RESULTS: The applicable scope, protocol design and quality control of the strengthening ECG monitoring study have been preliminarily explored. CONCLUSIONS: Based on the phase I clinical trials, cardiac safety of the new drugs is preliminarily evaluated and screened, without increasing drug exposure, and this study during phase I clinical trial will provide basis and reference for the further QT/QTc trial.