Drug Evaluation Committee 2022-27 Web-based Meeting of the Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
Initial release date: January 2023
Question
The IRB has continued to hold IRB meetings via the Web since 2020 based on "Q&A 20200526 for Conducting Clinical Trials of Drugs and Other Products under the Influence of New-type Coronavirus Infection" for the purpose of preventing infection by new-type coronaviruses.
Although there is a possibility that the infection will end and in-person meetings will be held in the future, several committee members have requested to continue holding meetings via the Web to reduce the risk of infection.
Although this temporary response to Q&A will not be permanent, we have been holding the meetings via the Web for more than two years, and since the exchange of opinions can be conducted appropriately, the Committee and the secretariat believe that the Web meetings are comparable to the face-to-face meetings and that it is possible to conduct deliberations equivalent to those held in a single meeting.
We believe that there is no problem in continuing to hold the meetings via the Web regardless of Corona, as described in " 2011-58 Holding of Clinical Trial Review Committee Meetings via Teleconference" by establishing procedures for holding and operating the meetings.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As you mentioned in your question, if the method of holding and operating the meeting is properly set up and operated in the same way as " 2011-58 Holding a Clinical Trial Review Committee Meeting by Videoconference," such as enabling interactive exchange of opinions, then we think there is no problem with web conferencing. Also, please refer to the past opinion " 2020-22 Convening a Clinical Trial Review Committee Meeting via the Web" when proceduralizing the operation method.