Drug Evaluation Committee 2009-38 Pros and Cons of Having the Establisher of a Clinical Trial Review Committee Become a Member
Related classification: Clinical Trial Review Committee
First published: January 2010
Question
GCP Article 28, Paragraph 1, Operational Notification 4 states that "The head of the site may attend a clinical trial review committee established by the site, but may not be a member of the committee or participate in its deliberations or voting. The head of the site may attend a clinical trial review committee meeting established by the site. However, the head of the site may not be a member of the investigational review committee established by himself/herself because he/she may influence the outcome of the deliberations of the investigational review committee. Is it possible for an establisher of a clinical trial review committee listed in Article 27, Paragraph 1, Items 2-8 to become a member of a clinical trial review committee established by itself and participate in deliberations and voting?
The same applies to the relationship between a clinical trial review committee and an establisher listed in Article 27, Paragraph 1, Items 2 to 8, as well as the relationship between a clinical trial review committee and an establisher listed in Article 27, Paragraph 1, Items 2 to 8, as the establisher generates revenue by entering into a contract for contract review, so the committee is likely to make a decision more favorable to the medical institution. The same is true of the relationship between the clinical trial review committee and the establisher as stated in Article 27, Paragraph 1, Item 2-8.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
We do not see any problem with the establisher of a clinical trial review committee listed in GCP Article 27, Paragraph 1, Items 2 to 8 becoming a member of such a committee. The reason why the head of a medical institution cannot be a member of a clinical trial review committee established by himself/herself is that "the head of the medical institution has a great deal of influence from his/her position as the head of the medical institution" and "the independence of the clinical trial review committee would be compromised because he/she would have to deliberate the matters he/she requested to be deliberated by him/herself". The above-mentioned investigative review committees are set up by the same person. Since the establisher of the above-mentioned clinical trial review committee is not the party who requests deliberations, its positioning differs from that of the head of the implementing medical institution in this respect. However, if the establisher of the above-mentioned investigational review committee concurrently serves as the head of a certain medical institution, he/she cannot participate in the review of clinical trials conducted at that medical institution (GCP Article 29, Paragraph 1, Guidance 7).
In addition, Article 27, Paragraph 2 of the GCP stipulates the requirements for a person who establishes a clinical trial review committee (establisher of a clinical trial review committee) as listed in Paragraph 1, Items 2 through 4. These requirements include those necessary to avoid influencing the deliberations of the Clinical Trial Review Committee.