Drug Evaluation Committee 2010-56 Permission/denial of IRB participation for Efficacy and Safety Committee members
Related classification: Clinical Trial Review Committee
Date of first publication: 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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The head of the medical institution, a principal investigator, or a 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 deliberation and vote 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.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Although the IRB is independent of the sponsor or the investigator, it is positioned as a committee that makes recommendations to the sponsor or the investigator who plans and sponsors the clinical trial regarding the continuation, modification, discontinuation, or suspension of the clinical trial (Article 19, Paragraph 1 of GCP). 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, a clinical trial review committee is a committee that is independent of the head of the medical institution, investigator and collaborator, but provides opinions on the appropriateness of conducting a clinical trial to the medical institution conducting the trial (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. We believe it is necessary that the results of deliberation and evaluation by the Efficacy and Safety Evaluation Committee and the results of deliberation and evaluation by the Clinical Trial Review Committee 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.