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.
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XUE Wei, LI Ke-xin. Strategy Discussion of Strengthening ECG Monitoring in Phase I Clinical Trials of Investigational New Drugs. Chinese Pharmaceutical Journal, 2015, 50(13): 1153-1155.
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