Drug Evaluation Committee 2015-15 Description of SAEs and the Number of Deviations in the Clinical Trial Status Report
Related classification: Clinical Trial Review Committee
Date of first publication: August 2015
Question
For a clinical trial with a long duration (6-8 years), is it acceptable to include only the number of SAEs and the number of deviations since the previous year's Investigation Status Report, rather than the cumulative total since the start of the clinical trial?
When the Clinical Trial Review Committee deliberates on the appropriateness of continuing the clinical trial, is the content of the most recent one-year status report insufficient? Personally, I think it should be stated as a cumulative total, but I cannot explain why the content of the most recent one-year implementation status is insufficient.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
A clinical trial implementation status report is a document submitted by the investigational review committee to review the appropriateness of continuing the relevant clinical trial (GCP Article 31, Paragraph 1; GCP Article 48, Paragraph 1, Guidance 1). Although GCP does not specify the specific contents of this report in detail, it is necessary to be able to appropriately grasp the status of the trial in question through this report in light of the purpose of the continuing review. If the status report of a long-term clinical trial includes only the status of a single year (since the previous report), it is important to be able to confirm the status of the trial to date, if necessary, during the review. One example would be to use the implementation status reports up to the previous report for the examination.
In any case, each individual Clinical Trial Review Committee should decide how much information to include in this report as necessary and sufficient information for continued review.