Drug Evaluation Committee 2018-49 Qualifications of Clinical Trial Review Committee Members (Part 2)
Related classification: Clinical Trial Review Committee
Date of first publication: 03/2019
Question
In the review of a clinical trial review committee for a company-led clinical trial, there is an external committee member who was previously involved in the development of the investigational drug in question, although he was not involved in the clinical trial under review (hereinafter referred to as "the clinical trial") itself. The committee member was the principal investigator of another clinical trial using the investigational drug, but he is not the Chairperson, principal investigator, or collaborator of the Investigator Site as defined in Article 29, Paragraph 1, Item 3 of the GCP, nor an officer or employee of the parent company or subsidiary company of the sponsor as defined in Article 29, Paragraph 1, Guidance 2 of the GCP, nor an officer or employee of an outsourced development organization as defined in Article 29, Paragraph 1, Guidance 3 of the GCP, nor an employee of an outsourced development organization as defined in Article 29, Paragraph 1, Guidance 3 of the GCP. Nor are they employees of the sponsor's parent company or subsidiary company, as exemplified in Article 29, Paragraph 1, Guidance 2 of the GCP. Is it correct to understand that such committee members can participate in the deliberation and voting of this clinical trial?
I ask this question because the committee member was previously involved in the development of the investigational drug and is more familiar with the investigational drug than the investigator of this clinical trial.
In asking this question, I have checked the past opinions 2009-16, 2009-40 and 2012-04.
JPMA's Opinion
Article 29, Paragraph 1 of the GCP is a regulation regarding conflicts of interest for members of a clinical trial review committee. In the case of your question, the committee member was engaged in another clinical trial for the investigational drug in the past as a principal investigator, but it has been confirmed that he/she does not have a close relationship with the sponsor of this clinical trial and is not the Chairperson, principal investigator, or collaborator of the Investigator Site for this clinical trial. In light of the above, we believe that there is no problem from the standpoint of fairness for the committee members to participate in the deliberation and voting on this clinical trial.
Therefore, we do not think it is necessary to consider that the member is in violation of GCP Article 29, Paragraph 1 and disqualified from participating in the deliberation and voting solely because he/she was a principal investigator in another clinical trial for the investigational drug in question in the past.