Drug Evaluation Committee 2010-18 Division of Roles between Specialized Clinical Trial Review Committees and their own Institutional Review Boards (Part 1)
Related classification: Clinical Trial Review Committee
First published: August 2010
Question
As a result of a questionnaire survey of IRB members at several sites, the following comments were received regarding the review of safety information.
The following comment was made in the survey: "Only the safety information provided by the sponsor should be reviewed by a separate review organization (IRB) such as Central IRB, and the results should be reported to the IRB of the investigational site to save time and effort. If the safety information has been properly reviewed by a specialized organization and that organization has determined that there is no problem with the continuation of the clinical trial, then there is no need to go to the trouble of having your own IRB review it."
I think it is true that there is no problem under GCP to hear opinions from multiple IRBs, but what about the fact that there is no need for review by one's own IRB because other IRBs have determined that there is no problem? Can this be addressed in the future?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stipulated in Article 30, Paragraph 4 of the GCP, if the head of the site deems it necessary to have the IRB investigate and deliberate on specific specialized matters that form the premise for determining the appropriateness of conducting a clinical trial, the head of the site may, with the consent of the investigational review committee concerned, request a hearing on such specialized matters by an investigational review committee other than the investigational review committee concerned (a specialized investigational review committee). In such a case, the opinions of a committee other than the relevant Clinical Trial Review Committee (Specialized Clinical Trial Review Committee) may be heard. In this case, as stipulated in Paragraph 5 of the same Article, the head of the site must report the opinions of the expert investigational review committee to the investigational review committee that heard the opinions regarding the appropriateness of conducting the clinical trial at the site. Furthermore, the latter committee must state its opinion on the appropriateness of conducting the clinical trial, based on the opinion of the expert investigational review committee (GCP Article 32, Paragraph 5).
The request for review by the Specialized Investigational Review Committee is based on the assumption that there are no members of the Investigational Review Committee who can provide expert opinions on the trial to be reviewed. We believe that a clinical trial review committee that has a specialized organization review the safety information in question is not fulfilling its responsibilities as a clinical trial review committee, and we recommend that the review be outsourced to an external clinical trial review committee.