Drug Evaluation Committee 2004-09 Scope of Minor Changes
Related classification: Clinical Trial Review Committee
First published: December 2004
Revised publication date: April 2013
Question
I would like to ask you about expedited review.
Our hospital's procedure document states the following.
The investigational review committee may conduct an expedited review for minor changes to an approved clinical trial within the clinical trial period.
The Chairman of the Trial Review Committee shall decide whether or not the change is subject to expedited review and the method of review.
A minor change is defined as a change in which the risk of the change is not greater than the risk of the subject's daily life or the risk of the physical or psychological examinations normally performed, excluding changes involving any physical invasive examinations.
The term "modification" is defined as "a change that does not involve any physical invasive tests.
We are considering adding more patients to the clinical trial that we are currently contracted to conduct.
Would such a case be considered a minor change?
Is it possible to obtain consent for more patients than the contracted number of cases at this time (we have contracted for 4 cases, 3 cases have been conducted, and consent has been obtained for 1 case, but the investigational drug has not yet been started)?
Furthermore, what would you define as a minor modification?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In Article 28, Paragraph 2, Guidance 2 (3) (iv) of the GCP, it is stated that minor changes related to an ongoing clinical trial that has already been approved by the investigational review committee may be reviewed through expedited review. Furthermore, "minor modification of an ongoing clinical trial" is defined as "a modification that does not affect the conduct of the clinical trial, is not likely to be mentally or physically invasive to the subject, and does not increase the risk to the subject. The "additional number of cases" is described as "additional number of cases".
As for "addition of the number of cases," unless it is an addition to the planned number of cases for the clinical trial as a whole, review by the Clinical Trial Review Committee is basically not required.
Reason for revision of opinion
In accordance with the issuance of the GCP Guidance (No. 1228/7 issued on December 28, 2012), the explanation regarding the necessity of a review by the Clinical Trial Review Committee for an additional number of cases has been changed.