Drug Evaluation Committee Translation: Statistical Issues and Recommendations for Conducting Clinical Trials under COVID-19 Pandemic Conditions
July 2020
The impact of the COVID-19 pandemic on clinical trials is spreading. To ensure the interpretability of our trials and maintain our chances of success, we must assess this impact and take the best possible measures. First, on May 11, we issued a statement as the DS Subcommittee.Subsequently, on July 9, a paper presenting statistical considerations was published in *Statistics in Biopharmaceutical Research* (SBR), one of the journals of the American Statistical Association. Because the paper contains a comprehensive discussion, we decided to translate it to raise awareness among our member companies. We translated it as KT-1 and published it on the JPMA website.The initial impetus came from an associate of Dr. Watanabe—who played a leading role—introducing the paper to us, as well as from Professor Hamazaki, who also brought the paper to our attention. Thanks to Professor Hamazaki’s communication with the American Statistical Association, SBR’s publisher Taylor & Francis, and other relevant parties, we were able to publish the translation shortly after the original paper’s release.Furthermore, we were able to publish it so quickly thanks to the efforts of the KT-1 members (Tomoki Oura, Hironori Yamazaki, Shingo Kuroda, Motoi Kotani, Katsu Tsuchikawa, Mikihiro Takamoto, Takashi Taniguchi; TF Leader Daisuke Watanabe, Kazumasa Takenouchi, and Vice Division Chair Hidenori Suganami), as well as the contribution of Mr. Kawamata (Kowa), who carried out a massive amount of editing work in a short period of time.
July 22, Reiwa 2
DS Subcommittee Vice Chair, TF Promotion Committee Member
Hidenori Suganami
The impact of the COVID-19 pandemic on ongoing clinical trials has widened. Biostatisticians should evaluate this impact and implement mitigation measures to maintain the interpretability of trials and their probability of success. A statement addressing this issue was published on May 11 on the JPMA website by the Data Science Expert Committee. A comprehensive article on statistical considerations was published in *Statistics in Biopharmaceutical Research*, an official journal of the American Statistical Association (ASA). It serves as a cornerstone for JPMA statisticians in developing mitigation plans for their clinical trials. To help disseminate this information more widely, we have translated this valuable article. There were two key starting points. Dr. Watanabe, one of the key contributors to this translation, was informed of the article through his professional connections. I learned that Prof. Hamasaki had shared this information with Japanese statisticians. When I approached him about the translation, he contacted the ASA Board of Directors, Taylor & Francis, and other stakeholders to request permission for the translation. This significantly expedited the process. We are very grateful to Professor Hamasaki for his contribution. I would also like to thank the KT-1 members (Mr. Oura, Dr. Yamasaki, Mr. Kuroda, Dr. Odani, Mr. Tsuchikawa, Mr. Takamoto) , the 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.D.