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薬理と治療
- Authors: Yumiko Asami1, Yutaka Noguchi2, Huei Wang3, Ying Zhou3, Denise Smith4
Abstract
Background While conducting statistical analyses in global drug development, statisticians and programmers across regions may face challenges due to the differences in regulation, language, and geographic region. This article proposes a process that facilitates appropriate and timely implementation of statistical analyses and regulatory responses. Methods Based on the experience of US and Japanese pharmaceutical companies in conducting global clinical trials and submitting new drug applications, we propose a process for implementing statistical analyses and regulatory responses irrespective of the locations of study team members. The process is based on gap analyses of regulations and practices regarding statistical analyses between regions, including consideration of different requirements for tables, listings, and figures between the Pharmaceuticals and Medical Device Agency(PMDA)and Food and Drug Administration(FDA). Results Through efficient resource utilization and early planning, Japanese and US teams were able to successfully deliver datasets and analyses for both PMDA and FDA submissions in a timely manner with high quality based on the proposed process. Conclusions A well‒defined process improves the efficiency and quality of PMDA submissions using global clinical trials. The current proposal facilitates the appropriate and timely conduct of statistical analyses using the Clinical Data Interchange Standards Consortium standards for global clinical trials and new drug applications.
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