Drug Evaluation Committee 2013-02 Agenda for the Summary of Clinical Trial Review Committee Meetings
Related classification: Clinical Trial Review Committee
First published: May 2013
Question
The following agenda is listed in the summary of the meeting record of the Clinical Trial Review Committee.
"Phase XX clinical trial for the disease indicated bythe investigational component symbol."
As the name of the sponsor was not listed on the agenda, we checked with the Clinical Trial Review Committee Secretariat, and they replied that there was no problem because the sponsor's name could be identified if the investigational component symbols were listed.
February 5, 2009, Ministry of Health, Labour and Welfare, Pharmaceutical and Food Safety Bureau, Review and Administration Division, "Q&A on Periodic Reporting of Adverse Effects of Clinical Trials and Preparation of Summary of Clinical Trial Review Committee Meeting Records," and GCP Article 28, Paragraph 2, Guidance 6, states that the agenda should include the name of the sponsor, phase of development, and target disease (in the case of Phase III trials), as well as the symbol of the trial component, the name of the sponsor, and the name of the investigational organization. The agenda should include the symbol of the component, the name of the sponsor, the phase of development, and the target disease (in the case of a Phase III study). Is there any problem if the sponsor's name is not stated as above?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The disclosure of the summary of the record of the meeting of the investigational review board (hereinafter referred to as "IRB") is established to improve the transparency and ensure the quality of the deliberations of the IRB, and the subjects and the general public are assumed to be the target of the disclosure. Against this background, we believe it is important that the summary of the meeting record be clear and easily understood by subjects and the general public when they read it.GCP Article 28, Paragraph 2, Guidance 6 states that the agenda items in the summary of the meeting record to be made public should include the following information: the symbol for the clinical trial component, the sponsor I assume that this provision was established so that subjects and the general public can easily identify the clinical trial.
The symbols for investigational new drug components in the agenda are identification symbols that the sponsor has established on its own, and each sponsor uses various symbols for different investigational new drug components at the same time, including in-licensed products and co-development products. Therefore, it is not easy for subjects or the general public to identify the clinical trial or sponsor from these symbols, and there is a possibility that they may be misunderstood. Therefore, we believe that the name of the sponsor should be listed in the summary of the IRB meeting record, in addition to the clinical trial component symbol, in accordance with Article 28, Paragraph 2, Guidance 6 of the GCP.