Drug Evaluation Committee 2009-17 Use of External Clinical Trial Review Committees by Medical Institutions with Clinical Trial Review Committees
Related classification: Clinical Trial Review Committee
First published: Jul. 2009
Question
Our facility has an in-house Clinical Trial Office and Clinical Trial Review Committee, and conducts clinical trial operations. We also have a business alliance with an SMO.
Recently, we received a request from a sponsor to use a clinical trial review committee affiliated with an SMO to review a new project. However, since our facility has a Clinical Trial Review Committee, we think it would be appropriate to have the review of the new case discussed by the Clinical Trial Review Committee at our facility.
In addition, the clinical trial in the previous phase of this case was discussed and conducted by the Clinical Trial Review Committee at our facility. Is there any problem in using the Central Clinical Trial Review Committee in spite of the fact that we are a facility that has established a Clinical Trial Review Committee? If we were to use the central committee, is there anything that we should keep in mind? Also, is there any problem under GCP for the sponsor to designate a committee as in this case?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 27, Paragraph 1, Guidance 2 of the GCP states that "The head of the implementing medical institution shall establish the procedures necessary for selecting an appropriate clinical trial review committee, and ... (omitted) ... appropriately select a clinical trial review committee for each clinical trial and request it to conduct investigation and deliberation. In addition, the head of the site must obtain the necessary information on the investigational review committee, etc., and select an investigational review committee that can conduct consistent investigations and deliberations from the start to the end of the clinical trial... (omitted)".
Therefore, if your facility's Standard Operating Procedures stipulate a procedure for selecting an external Clinical Trial Review Committee, there is no problem in using the so-called Central Clinical Trial Review Committee, even if the Clinical Trial Review Committee at your facility is deliberating the previous phase of the investigational drug in question. If you wish to use a central committee, you need to conclude a contract regarding the request for investigation and deliberation, and obtain a list of committee members and Standard Operating Procedures.
However, Article 27 of the GCP stipulates that the selection of the investigational review committee is the role of the head of the implementing medical institution, so the sponsor or SMO cannot designate the investigational review committee.