Drug Evaluation Committee 2009-44 Request for Review of Clinical Trial Review Committees of General Incorporated Associations of which the Head of the Performing Medical Institution is a Board Member

Related classification: Clinical Trial Review Committee

First published: Mar. 2010
Revised publication date: Mar. 2012

Question

Background

There are two hospitals (Hospital B and Hospital C) under General Incorporated Foundation A. We would like to request a clinical trial at Hospital B. General Incorporated Foundation A has established a Clinical Trial Review Committee, which reviews clinical trials to be conducted at Hospitals B and C.

Question 1

In the above case, it seems to be in violation of GCP Article 27, Paragraph 2, Operational Notice 5 (1), but is there any problem in requesting the review of the clinical trial to be conducted at Hospital B?

Question 2

What is the specific proposed action to conduct the clinical trial at Hospital B?

Question 3

GCP Article 27, Paragraph 2, Operational Notification 5 (1) states, "In cases where it is determined that a clinical trial review committee cannot be established at the medical institution concerned in accordance with the provisions of Article 27, Paragraph 1 of the GCP Ministerial Ordinance before the revision*, and where a general incorporated association or general incorporated foundation (general incorporated association, etc.), specified nonprofit corporation or academic society in which the head of the medical institution concerned serves as an officer is established, a clinical trial review committee may be established at the medical institution. This does not apply in cases where the head of the medical institution is unable to establish a clinical trial review committee, and the investigations and deliberations are conducted by a clinical trial review committee established by a general incorporated association or general incorporated foundation (general incorporated association, etc.), non-profit organization, or academic society in which the head of the medical institution is an officer.

In addition, Article 27, Paragraph 1 of the GCP before the revision* lists the following items as reasons why a clinical trial review committee may not be established at the relevant implementing medical institution.

How should these provisions be interpreted in judging this case?

Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

Question 1

With regard to the clinical trial review committees listed in Article 27, Paragraph 1, Items 2 through 4 of the GCP, Paragraph 2 of the same article stipulates the requirements for the establishers of such committees. Paragraph 2, item 6) "There shall be no other risk of impairing the fair and proper performance of the duties of the investigational review committee. In response to this, Article 27, Paragraph 2, Guidance 5 (1) of the GCP stipulates that "The officers of the establisher of a clinical trial review committee shall not include the head of the medical institution that makes the request to the said clinical trial review committee for investigation and deliberation or ... (omitted) ...". The provision states that "The director of the site where the investigational committee is to be established must not be included in the officers of the investigational committee. Therefore, in the case of your question, it is not possible to request the review of a clinical trial to be conducted at Hospital B to the Clinical Trial Review Committee established by General Incorporated Foundation A. However, if the establishment date of the Clinical Trial Review Committee of General Incorporated Foundation A is before March 31, 2008, and if there are sufficient reasons to explain that the Clinical Trial Review Committee cannot be established at Hospital B, the request can be made to the Clinical Trial Review Committee of General Incorporated Foundation A.

Question 2

The head of the site should select an appropriate committee in accordance with GCP and make a request for investigation and deliberation.

Question 3

The "the institution is small" and "it is difficult to secure persons with expertise in medicine or clinical trials" are considered to refer to institutions where it is difficult to secure a clinical trial review committee member or secretariat member who can adequately conduct investigations and deliberations at the clinical trial review committee. Although specific examples of "other reasons" are not explained in the previous operational notice, they may include, for example, medical institutions where the number of requests for clinical trials is small and it is difficult from the standpoint of efficiency to continuously hold and maintain a clinical trial review committee at the implementing medical institution.

Reason for revision of opinion

The term "incorporated foundation" was changed according to the "Act on General Incorporated Associations and General Incorporated Foundations" (enacted on December 1, 2008).

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