Drug Evaluation Committee 2010-56 Permission/denial of IRB participation for Efficacy and Safety Committee members
Related classification: Clinical Trial Review Committee
First published: Apr. 2011
Question
For clinical trials conducted by companies, GCP Article 29 (Meetings of the Clinical Trial Review Committee) stipulates the following members who are not allowed to participate in IRB deliberations and voting.
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Officers or employees of the sponsor or other persons who have a close relationship with the sponsor
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A person who conducts the clinical trial him/herself or a person who has a close relationship with the person who conducts the clinical trial him/herself
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Director of Investigator Site, investigator, or collaborator
In addition, in GCP Article 19 (Establishment of Effectiveness and Safety Evaluation Committee), Paragraph 1, it is expressed that the Effectiveness and Safety Evaluation Committee is a committee independent from the sponsor, investigator, and coordinating physician.
Also, from the Guidance 1 of GCP Article 19 (Establishment of Efficacy and Safety Evaluation Committee), if the Efficacy and Safety Evaluation Committee is established as a committee independent from the sponsor, investigator and coordinating physician, is it possible to interpret that the Efficacy and Safety Review Committee members can participate in the deliberations and voting of the IRB? Is this interpretation possible? Regarding investigator-initiated clinical trials, Article 26-5 of the GCP clearly states that IRB members and efficacy and safety evaluation committee members cannot serve concurrently.
JPMA's Opinion
Although the Efficacy and Safety Evaluation Committee is independent of the sponsor or self-initiated investigator, it is positioned as a committee that makes recommendations to the sponsor or self-initiated investigator that plans and sponsors the clinical trial regarding the continuation, modification, suspension, or discontinuation of the clinical trial (GCP Article 19, Paragraph 1 Guidance 1 and Guidance 2 of Article 19, Paragraph 1 and Paragraph 2 of Article 19, Paragraph 1 and Guidance 2 of Article 19, Paragraph 2 of GCP). On the other hand, the Clinical Trial Review Committee is a committee that is independent of the Chairperson of the Investigator Site, the investigator and the collaborator, but provides opinions on the appropriateness of conducting a clinical trial to the Investigator Site where the trial is to be conducted (GCP Article 27, Paragraph 1). In other words, the Efficacy and Safety Evaluation Committee and the Clinical Trial Review Committee are positioned as committees that state their opinions to the sponsor of the clinical trial and the investigator of the clinical trial, respectively. The head of the site, the investigator, and the investigator-in-charge must be independent of each other.
Therefore, even in a sponsor's clinical trial, we believe that it is undesirable for members of the Effectiveness and Safety Evaluation Committee to participate in the deliberation and voting of the relevant clinical trial as members of the Clinical Trial Review Committee.