Drug Evaluation Committee 2018-62 Necessity of Review by a Clinical Trial Review Committee at the Time of Transition from Clinical Trials to Post-Marketing Clinical Trials (Part 2)
Related classification: Clinical Trial Review Committee
Date of first publication: 2019-04
Question
This question is about the procedure for transitioning from a clinical trial to a post-marketing clinical trial.
The endpoints of clinical trials have changed, and there are now more opportunities to continue trials after obtaining approval for a new drug. In Japan, after obtaining approval, the drug will be transferred to post-marketing clinical trials, and I believe that the Clinical Trials Review Committee will accordingly require prior approval of the post-marketing clinical trial protocol and the explanatory documents for subjects. Since it is clear from the start of the clinical trial that this will happen by design, for example, the investigational protocol should state "that the terminology will be changed when the drug is transferred to a post-marketing clinical trial after obtaining approval" and the explanatory documents should state "that the drug will be transferred to a post-marketing clinical trial after obtaining approval and that the terminology will be changed" in advance. Is it possible to obtain approval for the clinical trial and future post-marketing clinical trials at the time of the initial review of the clinical trial? If this is possible, I understand that there is no need to hold a Clinical Trial Review Committee meeting immediately prior to the transition to post-marketing clinical trials and no need to obtain consent from the subject again.
As for the agreement with the medical institution, the "Questions and Answers on Handling of Implementation of Clinical Trials after Application for Approval of Pharmaceuticals (Office Communication) (February 5, 1999)" states that it is possible to take measures such as concluding an agreement with the medical institution in advance that "after approval, 'clinical trial' will be read as 'post-marketing clinical trial'", It can be read that if such an agreement is concluded prior to the start of a clinical trial, there is no need to re-conclude it before the start of a post-marketing clinical trial, but I could not read the above point.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As indicated in our previous opinion (2011-07), clinical trials and post-marketing clinical trials differ not only in the purpose of conducting each, but also in the calculation of costs, the burden of costs on subjects in terms of uninsured combined medical care costs, the handling of safety information, and in some cases, compensation. Therefore, when switching from a clinical trial to a study, it is necessary to do so with the correct understanding and consent of the subject, and it is necessary to obtain re-consent from the subject. When a clinical trial is converted to a post-marketing clinical trial, it is necessary not only to read the terms in the protocol and explanatory documents, but also to fully organize in advance the changes in subjects' interests that may occur due to the differences in applicable laws and regulations. Therefore, we believe it is important to conduct the review before the transition, not at the initial review.