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 Investigator Site from March 2017, when the continuation review was omitted, until the approval for continuation is obtained at the April review meeting at which the continuation review was 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 Investigator Site, it may not be appropriate to admit new subjects to the trial. 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 how to respond to the situation during the period until a continuation review is conducted and approved.

JPMA's Opinion

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 has not been reviewed by the Clinical Trial Review Committee as originally planned, so we believe that the Chairperson of the Investigator Site needs to make a decision on whether or not to continue the inclusion of new subjects based on the information and other factors related to the clinical trial obtained to date.

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.

Back to Clinical Trial 119 Top

TOP