Drug Evaluation Committee 2013-61 Requirement of Investigational Procedure Status Report for Survival Surveillance Period
Related classification: Clinical Trial Review Committee
Date of first publication: Apr. 2014
Question
In "Question No. 2010-16: Necessity of a continuation review near the end of a clinical trial," it is stated that "If all the administration of the investigational drug, subject visits, etc. have been completed, a continuation review is not required, but the procedure for submission of a termination report should proceed promptly. However, in recent trials, there are trials where "all the subjects' medications and visits to the hospital have been completed, but the termination report cannot be submitted for years because survival verification studies, etc., remain to be conducted. Currently, we submit a report with the same details every year for each continuing review by the Clinical Trial Review Committee, but we do not feel the need to deliberate on the matter. Even in such a case, is it safe to conclude that we do not need to submit an implementation status report for trials in which all subjects have been dosed and visited the hospital?
Opinion of the Pharmaceutical Cooperative Association
If the "Survival Confirmation Study" is an evaluation item stipulated in the study protocol, it falls under the "duration of the study" in Article 31, Paragraph 1 of the GCP, and is therefore subject to continuing review even if the study is conducted only as a survival confirmation study.
On the other hand, the purpose of the continuing review is to review the implementation status of the clinical trial from the perspective of protecting the human rights, safety and welfare of the subjects. If all subjects at your hospital have completed the administration of the investigational new drug and visits to your hospital for the clinical trial, and no new safety problems are expected to occur to the subjects as a result of the continuation of the clinical trial, it is possible to omit the continuation review at the discretion of the Clinical Trial Review Committee. In such a case, the fact that the investigational review committee has omitted the continuing review and the reason for such omission must be recorded, and the chief of the site and the sponsor must be notified.
Even if the continuing review is omitted, the investigator is required to report the status of the trial at least once a year to demonstrate that "no new safety problems have occurred in subjects as a result of the continuation of the trial," which is a precondition for omitting the continuing review.