Drug Evaluation Committee 2009-38 The pros and cons of having the establisher of a clinical trial review committee serve on the committee
Related classification: Clinical Trial Review Committee
First published: January 2010
Question
The GCP Article 28, Paragraph 1, Operational Notification 4 states that "The Chairperson of the Investigator Site may attend the Investigational Review Committee established by the Investigator Site, but may not be a member of the committee or participate in the deliberations or voting. The head of the site may attend a clinical trial review committee meeting established by the site. However, with regard to the establishers of the Investigator Sites listed in Article 27, Paragraph 1, Items 2 to 8, it is allowed to be a member of the Investigational Review Committee established by the Investigator Site itself and to participate in the deliberations and voting. 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 the Investigator Site and the establishers of the investigational review committees listed in Article 27, Paragraph 1, Items 2-8, as they generate revenue by entering into a contract for contract review. 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.
JPMA's Opinion
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 Chairperson of Investigator Site cannot be a member of a clinical trial review committee established by himself/herself is that "the Chairperson has a great deal of influence from his/her position as the head of the Investigator Site" and "the independence of the clinical trial review committee would be compromised because he/she would have to deliberate the matters he/she has requested to be deliberated by him/herself". The above-mentioned investigative review committees are set up by the same person. The establisher of the above-mentioned Clinical Trial Review Committee is not the party who requests deliberations, so its position differs from that of the Chairperson of Investigator Site in this respect. However, if the above Chairperson of a clinical trial review committee also serves as the head of an Investigator Site, he/she cannot participate in the review of a clinical trial conducted at that Investigator Site (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.