Drug Evaluation Committee 2007-12 Eligibility of Clinical Trial Review Committee Members
Related classification: Clinical Trial Review Committee
Date of first publication: Jan. 2008
Question
We would like to inquire about the composition of the Clinical Trial Review Committee when requesting a new clinical trial.
The medical institution (clinic) where we are planning to request a clinical trial has a clinical trial review committee, but I have a question about whether the committee can conduct an impartial review because the chairperson of the committee is the wife of the head of the medical institution. The head of the medical institution, who is also a candidate for principal investigator, claims that there is no problem because he considers living together and deliberation of the clinical trial separately.
The chairman is the only physician on the investigational review committee, and if he does not participate in the voting, there will be no more physicians.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Your question is about a case in which the spouse of the investigator (i.e., the head of the institution) is appointed as a member (chairperson) of the clinical trial review committee, but it does not fall under Article 29, Paragraph 1, Items 1-3 of the GCP, which stipulates that the spouse may not participate in deliberations and voting. Furthermore, Article 29, Paragraph 1, Guidance 1 of the GCP states in a supplementary clause that "Members who are related to the investigator shall not participate in the deliberation and voting on matters related to the clinical trial at the investigational review committee. However, it does not explain the specifics of whether or not the case in question falls under this "related" category.
Although it is not possible to determine that a committee member is inappropriate under GCP solely because he/she is the spouse of the investigator, it would be necessary to determine individually whether or not the chairperson concerned can give his/her opinion to the director from an independent standpoint.
In addition, Article 28, Paragraph 1 of the GCP stipulates that a clinical trial review committee must be "capable of fully discussing the clinical trial from ethical and scientific viewpoints," and Article 28, Paragraph 1, Guidance 10 of the GCP stipulates that "the clinical trial review committee may request the attendance and cooperation of experts in special fields who are not members of the committee. The GCP Article 28, Paragraph 1, Guidance 10 stipulates that "the clinical trial review committee may request the attendance and cooperation of experts in special fields other than the members. It may be important to confirm the opinion of the head of the institution (the establisher of the clinical trial review committee) regarding the fact that there is only one member with medical qualifications as the composition of the relevant clinical trial review committee, and to take measures such as proposing the addition of a member or requesting the cooperation of an expert other than a member.
Reason for revision of opinion
In accordance with the revision (October 24, 2011) of the "Implementation of Standards for Clinical Trials on Drugs," the commentary of GCP Article 29, Paragraph 1, Guidance 1 has been changed.