PMDA 举办了第10届数据科学圆桌讨论会，围绕肿瘤领域 Estimand、制药行业 R 语言应用、替代终点有效性评估三大主题进行了分组讨论，英文版讨论纪要已通过 PMDA 官网链接发布。该圆桌会汇聚日本关注药物开发、监管审评及相关统计方法的青年生物统计学家，本届为第10次会议。
We held the 10th Data Science Roundtable Discussion.
At this meeting, we engaged in group discussions on the following three topics. Summaries of these discussions (in English) are available at the links below:
Estimand in Oncology
https://www.pmda.go.jp/files/000282355.pdf
R in the Pharmaceutical Industry: Opportunities and Challenges
https://www.pmda.go.jp/files/000282353.pdf
Validity Assessment of Surrogate Endpoints Using a Practical Framework
https://www.pmda.go.jp/files/000282354.pdf
This event brings together young biostatisticians in Japan who are interested in pharmaceutical development, regulatory review, and related statistical methodologies. This was the 10th meeting of the Roundtable, which continues to provide a platform for open and lively discussions.
The name "Roundtable" reflects our intention to create a space where participants can freely exchange ideas with mutual respect—regardless of position or seniority—as if sitting around a round table.
We hope these materials will be helpful to you.We held the 10th Data Science Roundtable Discussion.
At this meeting, we engaged in group discussions on the following three topics. Summaries of these discussions (in English) are available at the links below:
Estimand in Oncology
https://www.pmda.go.jp/files/000282355.pdf
R in the Pharmaceutical Industry: Opportunities and Challenges
https://www.pmda.go.jp/files/000282353.pdf
Validity Assessment of Surrogate Endpoints Using a Practical Framework
https://www.pmda.go.jp/files/000282354.pdf
This event brings together young biostatisticians in Japan who are interested in pharmaceutical development, regulatory review, and related statistical methodologies. This was the 10th meeting of the Roundtable, which continues to provide a platform for open and lively discussions.
The name "Roundtable" reflects our intention to create a space where participants can freely exchange ideas with mutual respect—regardless of position or seniority—as if sitting around a round table.
We hope these materials will be helpful to you.
#RegulatoryScience #ClinicalTrial #Statistics
来源：独立行政法人 医薬品医療機器総合機構(PMDA) · x.com