Drug Evaluation Committee 2016-30 Resumption of Clinical Trials after the Submission of an Investigational Trial Termination Report
Related classification: Clinical Trial Review Committee
Date of first publication: October 2016
Question
In the ongoing Phase I trial at Hospital A, the enrollment and handling of subjects at the implementing medical institution has been completed. Since the trial as a whole has achieved its target number of subjects and there will be no further recruitment, the investigator prepared a report on the completion of the trial and reported it to the head of the site with a report on the completion (discontinuation or suspension) of the trial, and the head of the site notified the Clinical Trial Review Committee and the sponsor.
However, the sponsor is planning to revise the study protocol and has contacted us to ask us to conduct the study again with the establishment of a new cohort.
We would like to know if there is any problem in resuming the study for which we have submitted a termination report. If so, we would appreciate it if you could let us know if the following method would be acceptable.
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(1)The investigator and sponsor agree in writing to the withdrawal of the study termination report.
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(2)The investigator submits a letter to the head of the site withdrawing the study termination report, etc.
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(3)The head of the site notifies the Investigational Review Committee, and the Investigational Review Committee deliberates on the appropriateness of the continuation of the study.
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(4)After approval by the Investigational Review Committee, the clinical trial is resumed.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Although the GCP does not stipulate how to handle the case in question, we believe that there should be no problem in handling the case as you suggest. Alternatively, you could start the procedure with another request for a clinical trial. Regardless of the method, we think it is important to record the circumstances and reasons for restarting a clinical trial that has been terminated.
In your question, you mention "documents such as the withdrawal of the clinical trial termination report," but from the perspective of preserving the history, it is necessary to retain the clinical trial termination report that has already been submitted without discarding it.