Drug Evaluation Committee 2007-04 Clinical Trial Review Committees Established by Medical Corporations
Related classification: Clinical Trial Review Committee
First published: Aug. 2007
Revised publication date: Mar. 2012
Question
Please tell us about IRBs established by medical corporations (public comments indicate that medical corporations cannot establish IRBs).
(Background) Company A planned to conduct a Phase III trial as a sponsor; Company A entrusted a CRO (Company B) with those tasks from selection survey to monitoring; Company B requested a clinical trial to Clinic C (without an IRB), and Clinic C entrusted an IRB to Medical Corporation D (the Director who established the IRB). (The contract between Director C and D's IRB provider was already signed), the clinical trial was approved, and the first case of medication was started.
If the IRB was held after the date of publication of the results of public comments (June 7, 2006), what action should the sponsor take against Clinic C and Medical Corporation D, with whom the clinical trial has started?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The corporations that are allowed to establish a Clinical Trial Review Committee under Article 27, Paragraph 1 of the GCP are general incorporated associations, general incorporated foundations, and specified nonprofit corporations (so-called NPOs) based on the Law for the Promotion of Specified Nonprofit Activities (Article 2, Paragraph 2).
Medical corporations are corporations established in accordance with the provisions of the Medical Care Act (Article 39, Paragraph 1), and are not the aforementioned corporations. Therefore, it has not been permitted for a medical corporation (e.g., the chairman of the board of directors) to establish a Clinical Trial Review Committee.
Therefore, if the person setting up the committee is a representative of the medical corporation, it means that the review was requested to a committee that does not meet the requirements, and the clinical trial must be terminated promptly while taking the safety of the subjects into consideration. If the establisher of the review committee is the director of medical institution D, it is considered to fall under a clinical trial review committee established by the head of the implementing medical institution as stipulated in Article 27, Paragraph 1, Item 1 of the GCP (Guidance 1 (1) of Article 27, Paragraph 1 of the GCP states that it includes those established by the head of other medical institutions), and there should be no problem in continuing the clinical trial. There is no problem to continue.
Reason for revision of opinion
The term "incorporated foundation" was changed according to the "Act on General Incorporated Associations and General Incorporated Foundations" (enacted on December 1, 2008). In addition, the explanation in Article 27, Paragraph 1 of the GCP has been changed in accordance with the revision of the "Implementation of Standards for Clinical Trials on Drugs" (October 24, 2011).