Drug Evaluation Committee 2019-42 Clinical Trial Review Committee Review when the Director of the Establishing NPO is the Clinical Trial Coordinator
Related classification: Clinical Trial Review Committee
Date of first publication: December 2019
Question
If a director of a non-profit organization is a clinical trial coordinating physician on a clinical trial review committee established by the non-profit organization, is that considered to be a close relationship with the sponsor and the committee cannot review all of the sponsor's clinical trials while the director is serving as a clinical trial coordinating physician?
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1) Number of reports and countries from which data was obtainedI am not a member of the Clinical Trial Review Committee and will not participate in the deliberations because I am the president of the board of directors.
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2)The non-profit organization in question has 2 staff members, which is 1/5 of the entire Trial Review Committee members.
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3)In the answer to the previous question ( 2007-20 ), it is stated that "The coordinating physician... is defined as a physician or dentist who is commissioned by the sponsor," but it is also stated that "The coordinating physician is in the position of the medical institution and is not in the position to review cases or make decisions on acceptances or rejections, which should be performed by the sponsor. The "coordinating physician is the medical institution's representative, not the sponsor's.
From the above three points, it seems that there is no "possibility of impairing the fair and proper execution of the duties of the investigational review committee" under Article 27, Paragraph 2, Item 6 of the GCP. Please let us know.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In Article 27, Paragraph 1, Item 3 of the GCP, "a clinical trial review committee established by a non-profit organization as stipulated in Article 2, Paragraph 2 of the Act on the Promotion of Specified Nonprofit Activities (Act No. 7 of 1998)" is listed as one of the clinical trial review committees to which the head of the site can hear the opinions of the investigational One of the requirements to be met by the establisher of such a committee is stipulated in Article 2, Paragraph 2, Item 6 of the same article as "there is no other risk of impairing the fair and proper execution of the work of the investigational review committee". Guidance 5 (1) and (9) of Paragraph 2 of the same article states the following.
- The director of the medical institution at which the request for investigation and deliberation is made to the investigational review committee, or the investigator, subinvestigator or collaborator of the medical institution, or the director, employee or other person who has a close relationship with the sponsor of the clinical trial that is the subject of investigation and deliberation by the investigational review committee, or the director, employee or other person who has a close relationship with the sponsor of the clinical trial, must be an officer of the person who established the investigational review committee. (3) The investigator who establishes the clinical trial review committee is not included.
- (3) The investigator is not involved in the development of drugs related to the clinical trial that is the subject of investigation and deliberation as a business conducted by the establisher of the clinical trial review committee.
Since the business of the coordinator of the clinical trial is related to a specific clinical trial and the development of a specific drug, it is in conflict with the above "other business that is not likely to impair the fair and proper execution of the business of the investigative review committee," and during the period when an officer of the establisher of the investigative review committee (director of the NPO concerned) is serving in such business, this investigative review committee shall not be involved in the development of any drug related to the clinical trial that is the subject of the investigative review. The committee should not review all clinical trials for the drug in question during the period when the officer of the establisher of the committee (the director of the NPO in question) is serving in this capacity. However, we do not believe that this reason alone should preclude the TRC from reviewing the sponsor's other drug-related trials.