Drug Evaluation Committee 2019-03 Concurrent Membership of Clinical Trial Review Committees and Conflict of Interest Committees
Related classification: Clinical Trial Review Committee
Date of first publication: 2019-06
Question
This is a question about external members of the Clinical Trial Review Committee.
Our Clinical Trial Review Committee is set up by the president of the school corporation, and we have added a physician from another university as an external member. We have been asked to consult with him about appointing said external member as an external member of the Conflict of Interest Committee of our university as well.
The person setting up the Conflict of Interest Committee is the president of the school corporation, just like the Clinical Trial Review Committee. If the investigator has a conflict of interest with the sponsor, the conflict of interest committee will review it (the Clinical Trial Review Committee will review it based on the opinion of the Conflict of Interest Committee).
In such a case, if the member concerned becomes a member of the Conflict of Interest Committee of our university, would he/she be considered to have "a conflict of interest with the establisher of the Clinical Trial Review Committee" under the GCP? Or, would it be a problem if there is no compensation as a member of the Conflict of Interest Committee?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Since you mentioned in your question that you participated in the Conflict of Interest Committee in your capacity as an external member, we believe that if your involvement is limited to this, you can be considered a "person who does not have an interest in the establisher of the clinical trial review committee" as defined in Article 28, Paragraph 1, Item 5 of the GCP.