Rajman Iris, Hirano Masaru, Honma Wataru, Zhao Sylvia
Translational Medicine Asia, Novartis Institutes for Biomedical Research, Novartis NKK, Toranomon Hills Mori Tower, Tokyo, Japan.
Translational Medicine Asia, Novartis Institutes for Biomedical Research, Novartis NKK, Toranomon Hills Mori Tower, Tokyo, Japan.
Drug Discov Today. 2020 Mar;25(3):491-496. doi: 10.1016/j.drudis.2019.12.013. Epub 2020 Jan 8.
Some Asian regulators currently require Phase I data in Asians before joining global Phase II/III trials. Here, we discuss inherent limitations of Phase I ethnic sensitivity studies (ESS) to identify potential interethnic differences. We review recent new drug applications (NDAs) for Japan and China to critically assess the value of separate ESSs in Asian populations. Given that the observed value of ESS was limited, we propose a new global drug development paradigm: if relevant safety, pharmacokinetic (PK), and pharmacogenetic (PG) data are available from the original Phase I study population, it might be possible to extrapolate those data to Asian populations for their inclusion in Phase II/III trials, without an ESS. This could help to streamline drug development in Asia while still addressing regulatory requirements.
目前，一些亚洲监管机构要求在加入全球II/III期试验之前提供亚洲人群的I期数据。在此，我们讨论I期种族敏感性研究（ESS）在识别潜在种族间差异方面的固有局限性。我们回顾了日本和中国最近的新药申请（NDA），以严格评估在亚洲人群中单独进行ESS的价值。鉴于ESS的观察价值有限，我们提出了一种新的全球药物开发模式：如果从最初的I期研究人群中获得了相关的安全性、药代动力学（PK）和药物遗传学（PG）数据，那么有可能将这些数据外推至亚洲人群，以便他们能够纳入II/III期试验，而无需进行ESS。这有助于简化亚洲的药物开发，同时仍能满足监管要求。
