Drug Evaluation Committee 2007-24 Relationship between the Opinions of the Investigational Review Committee and the Decision of the Head of the Clinical Trial Site
Related classification: Clinical Trial Review Committee
First published: Jan 2008
Revised: Mar. 2012
Question
Please tell us about the role of the IRB, which I understand has the following roles.
- The IRB is not a decision-making body of a hospital.
- The hospital decides whether or not to conduct a clinical trial, and if it decides to conduct a clinical trial, the IRB's opinion is heard.
- If information on serious adverse drug reactions is obtained during a clinical trial, the responsible physician reviews it, decides whether or not to continue the clinical trial, and reports it to the hospital director (not specified in GCP).
- If the responsible physician's decision is that the clinical trial can continue, the hospital director asks for the opinion of the IRB → The IRB reviews the adverse event and makes a decision to approve (the responsible physician's decision), approve with conditions, reject, or revoke the approval already given.
- If the investigator's decision is to discontinue or suspend the trial, the hospital director notifies the IRB and the sponsor.
In short, the hospital first makes a decision and then listens to the IRB's opinion, not the hospital's decision based on the IRB's review results. First, please tell me if my understanding above is correct.
The only case in which the result of the IRB's deliberation differs from the hospital director's decision to direct the trial can be when the IRB approves the conduct or continuation of the trial and the hospital director denies it. This means that the IRB deliberation comes first, and then the hospital director decides whether to conduct or continue the clinical trial based on the IRB's deliberation.
What is your opinion on this?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 30, Paragraph 1, Guidance 1 of the GCP states that "The director of the implementing medical institution shall obtain the opinion of the Investigational Review Board (IRB) under Article 27, Paragraph 1 in advance regarding the appropriateness of conducting the clinical trial at the implementing medical institution. The head of the site is required to obtain the opinion of the Investigational Review Board (IRB) on the suitability of the clinical trial before deciding to accept the clinical trial. Therefore, the procedure described in your question is not "the hospital must first make a decision and then hear the IRB's opinion, not the hospital's decision based on the IRB's review results," but rather "if there is a possibility that the hospital will accept the clinical trial, the head of the site must hear the IRB's opinion, The correct understanding is to "make the final decision based on the IRB's opinion.
Reason for revision of opinion
In accordance with the revision (October 24, 2011) of the "Implementation of Standards for Conducting Clinical Trials on Drugs," the commentary in GCP Article 30, Paragraph 1, Guidance 1 has been changed.