Drug Evaluation Committee 2011-22 Necessity of Establishment of Clinical Trial Review Committee at the Sponsor
Related classification: Clinical Trial Review Committee
First published: Sep. 2011
Question
I would like to ask a question regarding the necessity of a clinical trial review committee within the sponsor.
When conducting a clinical trial, in order to examine whether the trial is ethically and scientifically appropriate for patients, the sponsor may first hold an internal "clinical trial review committee" to scrutinize the clinical trial materials such as the study protocol, and then the clinical trial review committee at the medical institution may scrutinize the materials.
- Is an in-house clinical trial review committee mandatory?
- If the sponsor does not have an in-house review committee, is there some other way to ensure this? Or is it sufficient to have only a clinical trial review committee at the medical institution?
- We do not have an internal clinical trial review committee organization in accordance with GCP. Therefore, we do not have an internal clinical trial review committee procedure manual. Even though we do not have a procedure manual or organization, can we consider that we have obtained approval from the internal clinical trial review committee by holding a committee meeting and obtaining approval from the members of the committee? The committee members will consist of the members stipulated in the GCP.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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GCP does not mention the establishment of an internal clinical trial review committee, so it is not mandatory.
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GCP Article 5 Guidance 2 has the following provision. The person who intends to request a clinical trial ... (omitted) ... must have sufficient data on quality, efficacy and safety to support the purpose of the clinical trial and the appropriateness of the target population, administration route, dosage regimen, administration period, observation items and evaluation items to be used in the clinical trial, from non-clinical studies such as physical chemistry studies, and from prior clinical studies. (2) The ethical and scientific validity of the clinical trial should be supported by sufficient data on quality, efficacy, and safety to support the validity of the route of administration, dosage and administration method, administration period, observation items, and endpoints, etc. In addition, the procedures for doing so shall be set forth in writing (see Article 4)." Therefore, the sponsor is required to have procedures (procedures) to guarantee the above, and a clinical trial review committee at the medical institution alone is not sufficient (the sponsor itself does not guarantee the above). The procedure varies depending on the organization and system of the sponsor.
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After preparing a procedure document in accordance with GCP Article 4.1, the sponsor must "assure that the ethical and scientific validity of the relevant clinical trial is supported" in accordance with the procedure.