Drug Evaluation Committee 2014-29 Commissioning of Clinical Trial Review Committee Reviews and In-House Clinical Trial Review Committees
Related classification: Clinical Trial Review Committee
Date of first publication: November 2014
Question
As an SMO, we provide secretariat services for implementing medical institutions. At the facility we are in charge of, an in-house IRB has been established, but we explained the recommendation to centralize the IRB and received conditional approval to outsource to an external Clinical Trial Review Committee. The conditions are as follows
- The director cannot decide to outsource to an external clinical trial review committee on his own initiative. When outsourcing to an external clinical trial review committee, the director should obtain the opinions of the committee members at the hospital IRB regarding the target disease, trial design, side effects, and information on the outsourced clinical trial review committee, and if the director approves, the outsourcing should be carried out.
- In the case of a clinical trial entrusted to an external clinical trial review committee, information that may affect the subject's decision, such as safety information, or the occurrence of a serious side effect in a subject in the hospital, shall be reported to the hospital IRB, and the Director shall hear the opinions of each committee member.
In the case of a clinical trial entrusted to an external Clinical Trial Review Committee, is it acceptable under GCP for the Director and each committee member to be informed of the information and for the Director to hear the opinions of each committee member, even though the IRB does not deliberate on the case? We are required to prepare the same materials as for review by the external clinical trial review committee. We are hoping to convene an external Clinical Trial Review Committee as well. We have explained that the review of a clinical trial entrusted to an external clinical trial review committee does not require review by the in-house IRB, but they do not understand that they should be informed about the clinical trial being conducted in the hospital.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The head of the implementing medical institution is required to establish the necessary procedures for selecting an appropriate clinical trial review committee (GCP Article 27, Paragraph 1, Guidance 2). If the head of the implementing medical institution cannot select the investigational review committee to which he/she entrusts the review, it is one way to ask the opinion of the investigational review committee that he/she has established.
The head of the implementing medical institution is allowed to hear the opinions of two or more clinical trial review committees (GCP Article 30, Paragraph 1, Guidance 2). However, if an in-house investigational review committee also conducts the usual review process, such as holding a review meeting and reviewing the protocol, in order to consider entrusting the review to an external investigational review committee, the procedure will become complicated and time-consuming. The clinical trial review committee to which the review is outsourced should be a committee capable of appropriate deliberation and evaluation from ethical, scientific, and medical/pharmacological perspectives (GCP Article 27, Paragraph 1, Guidance 2), so if the in-house clinical trial review committee is to review safety information, etc. during the clinical trial, the advantages of outsourcing the review to an external party should be taken advantage of. If the safety information, etc. is reviewed by the in-house Clinical Trial Review Committee during the clinical trial, the advantage of outsourcing the review to an external organization cannot be utilized.
Since the sponsor and the site would be required to perform a large amount of work to obtain opinions from two or more investigational review committees, we recommend that the director consider how to select the investigational review committee and the significance of outsourcing the review in the direction of requesting full review to a single investigational review committee.