Drug Evaluation Committee 2004-18 External Committee Members - Scope of "Persons with No Conflict of Interest with the Medical Institution (Part 1)
Related classification: Clinical Trial Review Committee
Date of first publication: Feb. 2005
Question
What are some cases in which it would be inappropriate for a person to have no direct interest in the hospital?
Example.)
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1.A pharmacist who manages a pharmaceutical wholesaler
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2.Former head of nursing department of a national hospital
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3.Former head of the pharmaceutical department of a national hospital
I don't think that 1. is out of the question, but what about cases 2. and 3.
If there are any other cases that are undesirable, please let us know.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
I interpret this as a question regarding the appropriateness of the members of the Clinical Trial Review Committee, and I would like to express my opinion on the matter.
The requirements for so-called external members and non-expert members of the Clinical Trial Review Committee, which are newly established by the GCP Ministerial Ordinance, have been discussed in the "Final Report of the Comprehensive Study on the Dissemination and Establishment of the New GCP" (FY1997 Health Science Research Group, March 1998) and other documents, but I don't think a unified conclusion has been reached, especially regarding the "interest" of external members. However, it seems that no unified conclusion has been reached, especially with regard to the "interests" of the external committee members.
(1) in the example is inappropriate because it is clearly judged as having an interest, while former employees who have retired in 2) and 3) are generally considered to have no interest (assuming no relationship at all, such as honorary position or advisory), but may express their opinions from the standpoint of the medical institution, so the view that this is not appropriate. ("How to proceed with a new clinical trial based on the new GCP," published by Mixsha on April 27, 1998).
Under these circumstances, if the medical institution (the establisher of the clinical trial review committee) judges that the person has no employment relationship with the medical institution and can express his/her opinion without being influenced by the medical institution, it would be acceptable to appoint him/her as an external member. If it is difficult to make this judgment, it would be better to avoid the appointment.