Drug Evaluation Committee 2013-17 Conflicts of Interest in Clinical Trial Review Committees Established by Non-Profit Organization
Related classification: Clinical Trial Review Committee
First published: March 2013
Question
A large hospital with more than 500 beds has had an in-house clinical trial review committee for 10 years and has been reviewing 10 to 15 new clinical trials per year. We received the following question from this hospital regarding the request for clinical trial review by a clinical trial review committee established by an outside non-profit organization. In particular, since conflicts of interest in clinical research and clinical trials have become a hot topic in recent years, please tell us from the perspective of conflicts of interest.
According to the NPO's Articles of Incorporation, its business activities include (1) support for research and development related to clinical trials, (2) operation of the Clinical Trials Review Committee and Ethics Review Committee, and (3) education on clinical trials, clinical research, and other medical-related information. There are 10 members of this Clinical Trial Review Committee, and one board member of the NPO is a member of the committee. In addition, three (of the four) board members of the NPO are expert members (part-time, do not participate in deliberations and voting, and provide opinions as advisors) of the committee.
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1.Is there any problem with an officer of a non-profit organization becoming a member of a clinical trial review committee established by the same organization?
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2.Is there any problem with a board member of a non-profit organization becoming an expert member of a clinical trial review committee established by the same organization?
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3.GCP Article 28, Paragraph 1, Guidance 10 states, "・・・・・ specialists are requested to attend the meeting and ・・・・", but in this Clinical Trial Review Committee, the term "expert member" is used. Should we change it to "expert" because it is confusing with the review committee members if we use "committee members"? Is it okay to leave it as "expert committee member"?
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4.If a non-profit organization is engaged in supporting the development of a drug for Pharmaceutical Company A as stated in its articles of incorporation (1), is there any conflict of interest issue in the fact that the clinical trial review committee is to review a product developed by Pharmaceutical Company A?
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5.If a member of the board is providing support for the clinical development of X, is it a conflict of interest for the clinical trial review committee to review Y, a product developed by Pharmaceutical Company A?
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6.Would there be a problem if a member of the board of directors concerned participates in the voting on the deliberations of a pharmaceutical company that has nothing to do with the project (1)?
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7.A non-profit organization is supporting the development of a pharmaceutical company A. May the above-mentioned expert committee member provide a reference opinion in the deliberation of a development product for which the matter to be deliberated by the relevant Clinical Trial Review Committee has a relationship with the pharmaceutical company A? Also, is it acceptable to give a reference opinion if it is not related to a product under development that we are currently supporting?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
(1)-(3)
As stated in Article 28, Paragraph 1, Guidance 7 of the GCP, officers of NPOs do not fall under the category of "persons who do not have an interest in the establisher of the clinical trial review committee," so they cannot be so-called "external members" as defined in Article 28, Paragraph 1, Item 5 of the GCP, but they can be other members of the committee. However, they can serve as other committee members. In addition, officers of NPOs can also cooperate as "experts in special fields other than committee members" as defined in Article 28, Paragraph 1, Guidance 10 of the GCP, so there is no problem with being a "specialist committee member" as you mentioned in your question. As for the need to change the term "expert committee member" to "specialist" or similar terms, this is an operational issue, not a GCP issue, so if it is deemed to be easily misunderstood, it should be handled accordingly.
(4)-(7)
We do not have detailed background information on the relationship between the NPO's Clinical Trial Review Committee and the sponsor, so we will avoid giving a definitive answer to these questions.
The site should be aware of the following points in Article 27, Paragraph 2, Guidance 5 of the GCP and determine whether or not the investigational review committee is a fair and appropriate review committee before using it.
- The board members of the establisher of the relevant clinical trial review committee must not include any person who has a close relationship with a pharmaceutical company, regardless of whether or not it is related to the clinical trial that is the subject of the investigation and deliberation by the relevant clinical trial review committee.
- (8) The establishment of the investigative review committee is not involved in the development of drugs related to the clinical trial that is the subject of investigation and deliberation as its business.
- (2) The applicant does not receive any financial support (including gifts of goods, provision of favors, etc.) from a pharmaceutical company related to the clinical trial that is the subject of the investigation and deliberation. (2) The investigator does not receive any support, etc. (including gifts of goods, favors, etc.) from pharmaceutical companies related to the clinical trial subject to the investigation and deliberation. (2) The investigator has not received any support, etc. (including gifts of goods and favors, etc.) from a pharmaceutical company related to the clinical trial subject to investigation and deliberation, unless it is generally recognized that the opinion of the investigational review committee on the implementation or continuation of the clinical trial will not be affected by appropriate conflict of interest management, etc.
- (2) The applicant must not hold shares in a commercial enterprise related to the clinical trial that is the subject of investigation and deliberation. However, this shall not apply if it is generally recognized that the opinion on the implementation or continuation of the clinical trial by the investigational review committee will not be affected by the implementation of appropriate conflict of interest management, etc.