Drug Evaluation Committee 2011-13 Scope of "Investigator-Related Committee Members" (Part 3)
Related classification: Clinical Trial Review Committee
First published: Aug 2011
Question
The same clinical trial that is currently being conducted at our hospital is also being conducted at another hospital, and our hospital's Clinical Trial Review Committee is entrusted with deliberating whether or not to continue the clinical trial at the other hospital. The investigators, subinvestigators, and collaborators at our hospital are completely different from the investigators, subinvestigators, and collaborators at the other hospital (they are not involved in the main clinical trial at the other hospital), but can they participate in the deliberations and voting on the main clinical trial at the other hospital?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
No. The Clinical Trial Review Committee must review the documents listed in each item of Article 10, Paragraph 1 of the GCP. Of these documents, the review of the protocol differs from the review of the appropriateness of the medical institution (equipment, facilities, staff, etc.), the eligibility of the investigator, or the explanatory documents prepared by the investigator. It is not appropriate for the investigators who conduct the clinical trial to participate in the review of the content of the trial plan from the viewpoint of the independence of the Clinical Trial Review Committee.
Therefore, the investigators, subinvestigators, and collaborators of your hospital are not allowed to participate in the deliberation and voting, even if they are not involved in the main clinical trial at another hospital.