Drug Evaluation Committee 2007-14 Adjournment of Clinical Trial Review Committee (Part 1)
Related classification: Clinical Trial Review Committee
Initial release date: Jan. 2008
Revised publication date: Mar 2021
Question
If an IRB that accepts a review from another medical institution closes its meeting due to difficulty in securing committee members, what will happen to a clinical trial that is being conducted at another medical institution?
Have there ever been any such cases? Is it possible to request another IRB to review the trial in the middle of the trial if there is a justifiable reason? (What other cases can you think of that would qualify as "legitimate" reasons?)
We would appreciate it if you could also tell us what procedures are necessary, including revising the explanatory documents to be provided to the subjects.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The closure of an Investigational Review Board (hereinafter referred to as "IRB") means that clinical trials being conducted at the investigational sites (hereinafter referred to as "investigational sites") reviewed by the IRB will no longer be subject to review as stipulated in Article 31 (Continuing Review, etc.) of the GCP. In this case, in order to protect the human rights, safety and welfare of subjects, which is the purpose of GCP, and to continue to ensure the scientific quality and reliability of the trial results, it would be appropriate to request another IRB to conduct the review.
The following items may be considered as the procedure for such a request.
- The head of the implementing institution selects a qualified IRB and concludes an agreement with it, taking into consideration consistent investigation and deliberation from the start to the end of the clinical trial, etc., in accordance with the purpose of Guidance 1 and 2 of Article 27, Paragraph 1 of the GCP.
- Provide the new IRB with the review-related materials (minutes, etc.) related to the relevant clinical trial to date from the IRB to be closed, and request the new IRB to review the relevant clinical trial along with the revised explanatory documents.
- The new IRB will review whether it is appropriate to conduct the relevant clinical trial based on the past deliberations. If the IRB concerned gives its opinion, the necessary action shall be taken.
- Notify subjects that the IRB has been changed, and provide explanations to new subjects in the revised explanatory document.
In addition, it is necessary to keep records related to the IRB as stipulated in Article 34 of the GCP. The records up to the closing of the IRB should be transferred to a designated place and person in charge of preservation after prior discussion between the establisher of the IRB, the head of the site and, if necessary, the sponsor.
In addition, Article 27, Paragraph 1, Items 2 through 4 of GCP lists the requirements for IRB establishers when the IRB receives a request for investigation and deliberation as Article 27, Paragraph 2, Item 6 of GCP, which states, "There shall be no other risk of impairing the fair and proper execution of the duties of the investigational review committee," and one of the items is, "The investigational review committee must be able to continuously conduct the clinical trial from its start to its end. One of the items is that "a system must be in place to continuously conduct investigations and deliberations on the clinical trial from the start of the clinical trial to its completion" (GCP Article 27, Paragraph 2, Guidance 5 (8)). Therefore, in closing the meeting and selecting the outsourced IRB, "the head of the site should obtain the necessary information on the investigational review committee, select a committee that is capable of conducting investigations and deliberations consistently from the start to the end of the clinical trial, and request the investigational review committee to conduct the investigations and deliberations" (GCP Article 27, Paragraph 1, Guidance 2). We believe it is necessary for the head of the site to prepare a document explaining "to select a clinical trial review committee that is capable of conducting investigations and deliberations consistently from the start to the end of the clinical trial and to request investigations and deliberations" (Article 27, Paragraph 1, Guidance 2).
The above is the view of the Japan Pharmaceutical Manufacturers Association (JPMA), but due to the significant impact of this case, we recommend that the regulatory authorities be consulted regarding necessary measures, etc.
Reason for revision of opinion
Due to the revision of GCP, consolidation of medical institutions, etc., it is no longer so rare for a Clinical Trial Review Committee to be closed, so some explanations have been changed.