Drug Evaluation Committee 2007-13 Attendance of a member who is a physician is required for the establishment of a Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
First published: Jan 2008
Revised: Mar. 2012
Question
A clinical trial review committee meeting was held at a medical institution after swearing an oath to convene the meeting in accordance with the institutional SOP. The agenda was as follows,
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Minor changes to protocols, etc.
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Deliberations on safety reports
- 2 additional reports of overseas safety information (already approved by previous IRB)
- One report of withdrawal of safety information overseas
- 2 new reports of safety information in Japan (events within the scope of possible events associated with the drug's action)
The committee consists of 3 physicians (external), 1 pharmacist, 1 nurse, and 3 clerical staff (1 external). Of these, 0 were physicians (absent on short notice), 1 was a pharmacist, 1 was a nurse, and 3 were clerical staff, for a total of 5 members.
The investigator and the monitor in charge of the clinical trial discussed the case, and although the physician was absent suddenly, the meeting was deemed to be valid based on the SOP and GCP.
- Sponsor's Opinion
- Not approved (Reason: Although this is a deliberation on a safety report, it is not allowed to be approved in the absence of a physician.
- Opinion of the implementing medical institution
- Approved
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It is appropriate to establish the meeting from the viewpoint of GCP and SOPs.
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It is questionable to conclude that the presence of two experts in the natural sciences (pharmacist and nurse) is not sufficient for safety deliberations without considering the backgrounds of the committee members. It is unfair to judge whether or not a case is approved or not based solely on the position of the committee members.
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The deliberations were based on the Q&A session between the investigators and the natural science experts and other attending committee members, and it may be a bit over-qualified to declare the safety report unsuccessful even in the absence of the physicians.
- Opinion of the inquiring party
- Approved (with a request: In principle, deliberations should be conducted in the presence of a physician as much as possible)
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Since the SOPs are included in the decision when selecting facilities, it would be unfair to declare that the safety report is not approved.
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However, in this case, questions and answers were held between a natural science specialist and the investigator, so I think it is a little over-qualified to declare the case unsuccessful.
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Judging from the point of view of the content of the safety report as well as the fact that the matter was submitted for discussion based on the accumulated information, it is a little over-qualified to declare that the matter approved in the situation described in 2. is not approved.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The composition of the Clinical Trial Review Committee is stipulated in Article 28, Paragraph 1, Guidance 1 of the GCP as follows: "The Clinical Trial Review Committee shall be composed of an appropriate number of members who have the qualifications and experience necessary to discuss and evaluate the clinical trial from ethical, scientific, medical, and pharmacological viewpoints, and who satisfy all of the following conditions. The committee shall meet all of the following conditions.
As background to your question, you mentioned that all three physicians appointed as members of the investigational new drug review committee were absent from the meeting and deliberations, and in such a case, the PMDA judged that "the operation of the investigational new drug review committee was inadequate (e.g., physicians did not participate in deliberations and voting on whether the clinical trial should be continued)". In some cases, the PMDA has judged that there was "inadequate operation of the Clinical Trial Review Committee (e.g., physicians did not participate in deliberation and voting on the appropriateness of continuation of the clinical trial).
Therefore, we recommend that the results of this deliberation be discussed again at the next Clinical Trial Review Committee meeting.
In your question, you mention that "the matter will be discussed by both the investigator and the monitor in charge" and that "the discussion will be based on the Q&A session between the natural science experts and other attending committee members and the investigator". However, please note that the investigator is only in a position to provide information and cannot participate in deliberation and voting (GCP Article 29, Paragraph 1, Guidance 6).
Reason for revision of opinion
In accordance with the revision (October 24, 2011) of the "Implementation of Standards for Conducting Clinical Studies on Drugs," the commentary in GCP Article 28, Paragraph 1, Guidance 1 has been changed. In addition, some explanations have been changed based on the results of past GCP field investigations that have been made public.