Drug Evaluation Committee 2021-40 Necessity of the review by the Clinical Trial Review Committee for changes in the clinical trial protocol after the completion of a clinical trial
Related classification: Clinical Trial Review Committee
Date of first publication: October 2021
Question.
I have a question regarding changes to the clinical trial protocol after the completion of a clinical trial.
The ongoing clinical trial is a multicenter clinical trial, and the clinical trial itself has been completed at each site, and at this point, the investigators at all sites have submitted completion reports to the heads of the sites.
Although the work on the medical institution side has been completed in this way, due to changes in the specifications of the data analysis system, there is a high possibility that some of the analyses described in the protocol will not be performed.
In the event that the clinical trial protocol is actually changed, the in-house ethics committee plans to implement the procedures for changing the clinical trial protocol, but since the clinical trial has already ended at each medical institution, it is not possible to review the updated clinical trial protocol. The changes to the protocol are only that some of the planned analyses will not be conducted, and are not related to the ethical aspects of the subjects.
In this case, is it acceptable for the site to proceed with the analysis by implementing the procedures for changing the protocol only by the in-house ethics committee, without having the changed protocol reviewed by the investigational review committee?