Drug Evaluation Committee 2008-04 Clinical Trial Review Committees Established Jointly by Multiple Medical Institutions - Change in the Composition of the Establishers
Related classification: Clinical Trial Review Committee
Date of first publication: August 2008
Question
Background of the Clinical Trial Review Committee
- Clinical Trial Review Committee jointly established by Hospital Director A, Hospital Director B, and Hospital Director C (all three are medium-sized facilities)
- The name is D Clinical Trial Review Committee
- The location of the Clinical Trial Review Committee is the address of the SMO (the secretariat is also located in the SMO)
- The committee receives requests from neighboring hospitals to review clinical trials and reviews about 20 trials per month.
Is it possible to change the form of the Clinical Trial Review Committee as follows? If so, what procedures should be followed?
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1.If Hospital Director A requests to establish a separate Clinical Trial Review Committee within Hospital A, can Hospital Director B and Hospital Director C alone keep Hospital D's Clinical Trial Review Committee in existence?
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2.If the Director General of Hospital B and the Director General of Hospital C both offer to resign as the establisher of the D Clinical Trial Review Committee, can the D Clinical Trial Review Committee continue to exist with only the Director General of Hospital A? In this case, can the name (and location) be changed?
In addition, we would like to know if there are any other cases in which an IRB that was conducting investigations and deliberations during a clinical trial was transferred to another IRB.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In the case of 1. in your question, it would be possible to transfer the IRB as a joint IRB established by the Presidents of Hospitals B and C, and in the case of 2. in your question, it would be possible to transfer the IRB (by closing the jointly established D IRB) and establish a new IRB solely by the President of Hospital A. The procedures for changing the establisher of the Clinical Trial Review Committee may include the following.
- Revision of the record of establishment of the Clinical Trial Review Committee (GCP Article 27)
- Revision of the protocol of the Clinical Trial Review Committee (GCP Article 28)
- Re-election of the members of the Clinical Trial Review Committee (GCP Article 28)
- Re-election of the secretariat of the clinical trial review committee (GCP Article 28)
- Revision of the description of the investigational review committee in the explanatory document (GCP Article 51)
- Conclusion of a change agreement with the medical institution to which the review is entrusted and submission of the revised procedure manual and list of committee members (GCP, Article 30)
The GCP requires that the same clinical trial review committee continuously conduct investigations and deliberations from the start to the end of the clinical trial (GCP Article 27, Paragraph 1, Guidance 2). Therefore, in both 1. and 2. of your question, a clinical trial that has been reviewed by the Clinical Trial Review Committee D as to whether it is appropriate to start the clinical trial must be reviewed by the said Clinical Trial Review Committee until the trial is completed. In other words, it is not possible to entrust the review to the Clinical Trial Review Committee established solely by Hospital Director A (including Case 2.) from the middle of a clinical trial.
We are not aware of any cases regarding the transfer of a clinical trial review committee under the background of your question. The above is the view of the Japan Pharmaceutical Manufacturers Association (JPMA), but due to the extremely large impact of this case, we recommend that you consult with the regulatory authorities regarding necessary measures, etc.