Author: Sarah M. Robertson, PharmD on October 09, 2018
Few topics have received greater interest in the world of early clinical development over the past year than the updated EMA Guidelines on First-in-Human and Early Clinical Trials, finalized in July 2017. Following release of the revised guidelines, the pharmaceutical industry has taken a close look at our current practices during first-in-human (FIH) trials, reflecting on what works, what doesn’t, and how we might evolve in partnership with regulators. One year after the finalization of the EMA FIH Guidelines, Clinical and Translational Science (CTS) published a Tutorial on “Design and Conduct Considerations for First-in-Human Trials,” by Dr. Jie Shen et al. This tutorial is both timely and relevant, covering topics related to preclinical safety testing, dose selection, study design, safety monitoring, and the utility of biomarkers.
Since the re-launch of CTS in 2016, Tutorials have become a valuable and highly-regarded article type for CTS readers. They are educational pieces written to provide practical guidance on aspects related to the tools, methodologies, and approaches to translational medicine. Tutorials are typically authored by experienced scientists and intended to educate trainees and individuals less familiar with a particular field, but they are also at a level that experienced scientists will find valuable as a resource. The CTS editorial team is always happy to consider proposals or suggestions for Tutorial topics that may be of interest to our readers.
Image by Shen, et al. Clin. Trans. Sci., doi.org/10.1111/cts.12582, is licensed under CC BY-NC 4.0. ©2018 The authors.
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