Drug Evaluation Committee 2017-15 Actions to be taken in case of delay in continuation review

Related classification: Clinical Trial Review Committee

Date of first publication: July 2017

Question

Background (example)

In the above case, should the inclusion of subjects be suspended at the site from March 2017, when the continuation review was delayed, until the approval for continuation is obtained at the April review meeting when the continuation review is conducted?

As long as the purpose of the Continuing Review is not to examine the appropriateness of continuing the clinical trial and whether or not it is being conducted appropriately at the site, it may not be appropriate to incorporate new subjects. However, in situations where a subject is participating in a clinical trial, it is possible that suspending the trial may cause disadvantages to the subject. We would appreciate it if you could provide us with information on the measures to be taken during the period until the continuation review is conducted and approved.

Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

The purpose of the continuing review by the Clinical Trial Review Committee is to review the status of the clinical trial from the perspective of protecting the human rights, maintaining safety, and improving the welfare of the subjects, and to determine whether or not it is appropriate to continue the clinical trial.

In this case, the clinical trial was not reviewed by the clinical trial review committee as originally planned, so we believe it is necessary for the head of the site to make a decision on the appropriateness of continuing the inclusion of new subjects based on the information obtained so far regarding the clinical trial.

For subjects who are already participating in the clinical trial, there is no problem with continuing the clinical trial because of the possible disadvantages of temporarily suspending the clinical trial.

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