Drug Evaluation Committee Translation: Statistical Issues and Recommendations for Conducting Clinical Trials under the COVID-19 Pandemic
Data Science Subcommittee
July 2020
The impact of the COVID-19 pandemic on clinical trials is widespread. We need to assess its impact and take the best possible measures to ensure the interpretability of our trials and to preserve their probability of success. First, on May 11, we issued a statement as the DS Subcommittee. Then on July 9, a statistical discussion paper was published in Statistics in Biopharmaceutical Research (SBR), one of the official journals of the American Statistical Association. Since the discussion was comprehensive, we decided to translate the article as KT-1 and publish it on the JPMA website in order to make it widely known to our member companies. The initial impetus came from Dr. Watanabe, who played a leading role in introducing the paper to us, and from Prof. Hamasaki, who introduced the paper to us. Professor Hamasaki's communication with the American Statistical Association, Taylor and Francis, the publisher of the SBR, and others involved allowed for early publication of the original paper. The prompt publication was also made possible by the members of KT-1 (Tomonori Oura, Hironori Yamazaki, Shingo Kuroda, Motoi Kotani, Masaru Tsuchikawa, Mikio Takamoto, Takashi Taniguchi, and TF leader Daijo Watanabe). TF Leader: Daijo Watanabe, Kazumasa Takenouchi, and Vice Chair: Hidenori Suganami), and also thanks to Mr. Kawamata (Kowa) for his enormous editing work in a short period of time.
July 22, 2020
DS Subcommittee Vice Chair TF Promotion Committee Member
Hidenori Suganami
An impact of the COVID-19 pandemic for ongoing clinical trials has been expanded. Biostatisticians should evaluate its affect and conduct mitigation to A statement about this issue was published in 11th May on JPMA's website by data science expert committee. A comprehensive statistical consideration article was published in Statistics in Biopharmaceutical Research, an Official A comprehensive statistical consideration article was published in Statistics in Biopharmaceutical Research, an Official It is a cornerstone for statisticians in JPMA to consider mitigation plan of their clinical trial. In order to accelerate spreading this, we translated this valuable article. there are two starting points. relations of Dr. Watanabe who is one of the main person of this translation informed him. When I asked him about the translation, he communicated ASA Board of Directors, Taylor and Francis and stakeholders to request the translation. It made this task faster. We are very grateful to Professor Hamasaki for his I would also like to thank the KT-1 members (Mr. Oura, Dr. Yamasaki, Mr. Kuroda, Dr. Odani, Mr. Tsuchikawa, Mr. Takamoto) ,TF leaders (Dr. Watanabe, Mr. Takenouchi) and others. TF leaders (Dr. Watanabe, Mr. Takenouchi ) and Ms. Kawamata (Kowa) for their contributions.
Vice-chairperson Data Science Expert Committee, task force leader
Hideki Suganami, Ph.
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