Drug Evaluation Committee 2019-41 Frequency of Clinical Trial Review Committee Meetings
Related classification: Clinical Trial Review Committee
Date of first publication: December 2019
Question
We plan to change the frequency of meetings of the Clinical Trial Review Committee established at our site from monthly to bi-monthly for convenience. When we sought opinions from several sponsors and CROs in advance about reducing the frequency of the Clinical Trial Review Committee meetings, we received the following comments from one of the sponsors.
- 1.Since the period between the most recent Clinical Trial Review Committee meeting will be extended by up to one month, it would be better to indicate the policy of the site and Clinical Trial Review Committee on how to respond to reports and deliberations related to subject safety when they occur.
- 2.While most clinical trial review committees review at least once a month, can it be said that this medical institution is able to review safety information in a timely manner with a frequency of once every two months?
From the viewpoint of ensuring the safety of subjects, please explain what specific measures should be taken, as well as the rationale for such measures. We consider the following as major examples of "events related to the safety of test subjects.
- a.Serious adverse events occurring at another site that may affect the willingness of subjects at the site to continue in the trial.
- b.Reports of serious adverse events occurring at the home institution
With regard to a., I believe that the provision of information to individual subjects and the handling of the discontinuation of subjects who wish to continue the clinical trial will be conducted promptly without waiting for the results of the review by the Clinical Trial Review Committee, as has been the case in the past, and I believe that this will not increase the risk to subjects.
Regarding point b., we think it is desirable in principle to have the Clinical Trial Review Committee discuss the trial, including whether or not to continue the trial, as soon as possible, but we would like to know if it is sometimes judged that one month later is good but two months later is too late, and the basis for this decision.
The SOP of our hospital's Clinical Trial Review Committee states, "However, the Clinical Trial Review Committee may convene at any time when the Director urgently requests its opinion. We would like to maintain SOPs as necessary so that we do not have to respond to emergency meetings as much as possible.
Opinion of the Pharmaceutical Manufacturers Association
GCP does not stipulate the frequency of meetings of the Clinical Trial Review Committee. However, Article 32, Paragraph 3 of the GCP stipulates as the responsibility of the Clinical Trial Review Committee that "...the committee shall state its opinion in writing promptly in accordance with the urgency of the situation pertaining to the matter for which it has been asked for its opinion. In addition, Guidance 3 of the same article states that "...matters on which opinions shall be given promptly due to the urgency of the situation shall be clarified in advance by the written procedures stipulated in Article 28, Paragraph 2." Therefore, it is necessary to develop and operate a procedure manual to fulfill the responsibilities of the Clinical Trial Review Committee. If the interval between meetings is changed while the trial is in progress, we believe that sufficient explanation should be provided regarding the impact of the change before and after the change.
In addition, it is assumed that a change in the meeting interval will increase the possibility of urgent examinations. In particular, changes to the protocol and explanatory documents for subjects cannot be implemented without the approval of the Investigational Review Committee, so a delay in the review by the committee may affect human rights and safety of subjects. We think it is even more important to have a system in place, including the coordination of attendance by outside committee members, so that urgent reviews can be held smoothly when necessary.