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
GCP Article 28, Paragraph 1, Operational Notification 4 states that "The Chairperson 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 the deliberations or voting. The head of the site may attend a clinical trial review committee meeting established by the site. However, the chairpersons of the investigational review committees listed in Article 27, Paragraph 1, Items 2 to 8 are not allowed to be members of the investigational review committees established by the investigational review committees themselves. 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 the establishers listed in Article 27, Paragraph 1, Items 2 to 8, as well as the relationship between a clinical trial review committee and the establishers listed in Article 27, Paragraph 1, Items 2 to 8. 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 a medical institution 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 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 has 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 Chairperson of the implementing medical institution in this respect. However, if the above Chairperson of a clinical trial review committee also serves as the head of a certain medical institution, he/she cannot participate in the review of a clinical trial 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.