Drug Evaluation Committee 2008-17 Scope of External Members - "Persons with No Conflict of Interest with the Performing Medical Institution" (Part 2)
Related classification: Clinical Trial Review Committee
First published: January 2009
Question
I would like to ask you about the interests of external committee members in a clinical trial review committee.
This medical institution is a hospital affiliated with a certain company. An employee of the parent company serves as an external member of the clinical trial review committee of this medical institution.
Article 28, Paragraph 1, Item 4 of the GCP states that "Of the committee members, those who do not have an interest in the medical institution must be included. The medical institution is of the opinion that since the organization is separate, there is no problem with having this staff member as an external committee member.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As you pointed out, Article 28, Paragraph 1, Item 4 of the GCP stipulates that "Among the committee members, those who do not have any interest in the implementing medical institution must be included. This provision is explained in Article 28, Paragraph 1, Guidance 5 of GCP, but it does not mention cases such as the one you are asking about. However, if the external committee member (an employee of the parent company of the implementing medical institution) is not involved in the operations of the implementing medical institution, he or she is considered to be a "person who does not have an interest in the implementing medical institution. However, if such a committee member is in a position that could strongly influence the operations of the implementing medical institution, such as being an officer or manager of the parent company, or is in a position that could be strongly influenced by the occurrence of a problem at the company that established the implementing medical institution, he/she would be considered inappropriate as an external committee member.
However, the measure of "strong influence" is considered to vary depending on various backgrounds, such as the scope of the duties and authority of the committee members, etc. Therefore, it is necessary for the sponsor to determine the appropriateness of the committee members individually based on the information provided by the clinical trial review committee/executing medical institution.