Drug Evaluation Committee 2012-19 Handling of Comments from Absent Members at Clinical Trial Review Committee Meetings
Related classification: Clinical Trial Review Committee
First published: August 2012
Question
There will be a second IRB review for a clinical trial for pediatric subjects that has already passed the initial review for clinical trial implementation. The case is the safety information described in "Form 16, Report on Safety Information, etc." with the following information.
- Summary of Adverse Events, etc.
- 3. "Serious, congenital abnormality, etc. (unknown) in accordance with 1 or 2", periodic report
- Sponsor's Opinion
- Continuation of clinical trial = acceptable, Revision of study protocol = not required, Revision of explanation document and consent document (sample) = not required, Others = none
- Attachment
- Common Line List for Individual Report, Periodic Report Form for Serious Adverse Reactions to Investigational Drugs, List of Incidents of Serious Adverse Reactions
For the IRB review of the above case, if the IRB member specializing in pediatrics is unable to attend the IRB review, the sponsor has requested to receive comments before the IRB from the member concerned on the attached form. At the next IRB meeting (the second IRB meeting), it is difficult for the pediatric IRB member to attend, but the IRB requirements under GCP can be met sufficiently. Thus, even if the IRB is not an initial review, but only a review of periodic safety information, are the comments of a pediatric specialist committee member always required in advance under GCP?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 28, Paragraph 2, Guidance 3 of the GCP states that "The requirements for the establishment of a clinical trial review committee meeting must meet the requirements of Article 28, Paragraph 1 of the GCP," and Article 28, Paragraph 1, Item 1 of the same article states that the clinical trial review committee must be "capable of fully deliberating the clinical trial from an ethical and scientific perspective. "The committee must be able to sufficiently deliberate on the clinical trial from ethical and scientific viewpoints. The same article, paragraph 1, item 1 stipulates that the clinical trial review committee must be "capable of sufficiently deliberating the clinical trial from an ethical and scientific perspective. In addition, Article 29, Paragraph 2 of the GCP stipulates that "a member who does not participate in the deliberation may not participate in the voting. Therefore, before holding a meeting, the Investigational Review Committee must not only confirm the attendance of non-expert committee members/external committee members and the number of attending committee members, but also determine "whether or not (only attending committee members) can sufficiently deliberate the clinical trial from an ethical and scientific viewpoint.
In the case of your question, if the IRB determines that the opinion of the pediatric IRB member is "necessary to fully discuss the clinical trial from ethical and scientific viewpoints" (i.e., necessary for the meeting to be successful), then the IRB must have the said member in attendance, and submission of comments alone is not sufficient. Submission of comments alone is not sufficient. On the other hand, if the investigational review committee judges that "sufficient deliberations can be conducted from ethical and scientific viewpoints" even if the IRB member concerned is absent, it is not necessary to have the absent IRB member submit comments.
Guidance 10 of Article 28, Paragraph 1 of the GCP states, "The investigational review committee may request the attendance of and obtain the cooperation of experts in special fields other than the members of the committee. This is stated in the Guidance. If the absence of the IRB member who specializes in pediatrics is unavoidable and it is difficult to conduct "sufficient deliberation from ethical and scientific viewpoints" during the deliberation of the clinical trial, the investigational review committee may, at its discretion, invite "experts in special fields other than pediatrics" to participate in the deliberation.