Drug Evaluation Committee 2011-07 Necessity of Review by a Clinical Trial Review Committee at the Time of Transition from Clinical Trial to Post-Marketing Clinical Trial
Related classification: Clinical Trial Review Committee
Initial release date: 2011-07
Revised publication date: December 2021
Question
We received a request from a sponsor to continue a Phase III study that is scheduled to be submitted for approval, and to move to a post-marketing clinical study after approval. Since this is a long-term study and the consent document states 5 years (60 months), and since the sponsor also has data to collect, we are considering a "Memorandum of Understanding" to replace "clinical trial" with "post-marketing clinical study" until the term of the original agreement (approximately 3 more years).
In this case, do we need to request a review by the Clinical Trial Review Committee (by submitting a change application and a change agreement)?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in Article 56, Guidance 2 (4) (viii) of the GCP, "Approval for conducting a post-marketing clinical study must be obtained in advance from the investigational review committee of the site where the post-marketing clinical study will be conducted. (4) (viii)).
In addition, clinical trials and post-marketing clinical trials differ not only in the purpose of conducting each, but also in the standards for calculating the expenses required for the clinical trial/trial (e.g., uninsured combined medical care expenses, which are borne by the patient).
Therefore, when switching from a clinical trial to a post-marketing clinical trial, it is necessary to obtain approval from the Clinical Trial Review Committee in advance, along with revisions to the explanatory documents accompanying the change in the purpose and cost of the trial and the patient-paid portion.
In addition, Article 56 Guidance 2 (4) (viii) of GCP further states that "it is also acceptable to obtain approval from the Clinical Trial Review Committee to continue the clinical trial as a post-marketing clinical trial after the approval date before the approval date. It is recommended that the sponsor and the site consult with each other regarding the timing of the request for review.
Reason for revision of opinion
The opinion text has been partially changed in accordance with the issuance of the GCP Guidance (July 30, 2021, Pharmaceutical Affairs Council of Japan, No. 0730-3).