Revelation of French BIA 10-2474 Clinical Trials to Chinese Investigators

Abstract

Abstract: Objective To provide some suggestions for the investigators who are engaged in phase I clinical trial First-In-Human or related clinical trials in China through making a detailed introduction to the first human trial event in phase I of French BIA 10-2474 clinical trial. Methods A case study was conducted to analyze the clinical phase I study of BIA 10-2474 in France. Results and Conclusion To the first-in-human clinical trials, investigators in China should pay attention to the design of starting dose, making correct decision to terminate the incremental rule, setting up risk control measures, guaranteeing the safety of the subjects, enhancing the overall level of clinical research.

Key words: French BIA 10-2474, innovative drugs, first-in-human clinical trial, investigators , revelation

CLC Number:

LI Jiang-fan, XUE Wei, HU Xin, LI Ke-xin. Revelation of French BIA 10-2474 Clinical Trials to Chinese Investigators[J]. Chinese Journal of Pharmacovigilance, 2018, 15(2): 94-97.

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