Drug Evaluation Committee 2018-03 Review of Clinical Trial Protocols, etc. in English Only
Related classification: Clinical Trial Review Committee
Date of first publication: June 2018
Question
This question is about the timing of the Clinical Trial Review Committee meeting when revisions are made to the protocol, drug summaries, etc., for which English is used as the original language in clinical trials.
All of the members of the Clinical Trial Review Committee at our hospital are Japanese, and it is difficult for all of them to understand English documents with a level of comprehension similar to that of Japanese documents. Therefore, in order to ensure the accuracy of the committee's review, even if the English document (original) is provided, the committee waits for the Japanese version of the document to be provided afterwards before it is reviewed by the Trial Review Committee.
One of the monitors asks us every time if the Clinical Trial Review Committee can review the English document alone, because the PMDA considers it undesirable because it looks as if the sponsor approves of delaying the deliberation until the Japanese version is available, even though the English version is the original document. Although the Japanese version is only a supporting document, is it a bad thing to postpone the Trial Review Committee's review until the Japanese version is available, even though it is clear that the Japanese version cannot be understood properly without reading it?
There is no mention of "fluency in a foreign language" as a requirement for a Clinical Trial Review Committee member, so how should we deal with this in the future?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The sponsor must keep up-to-date the documents to be submitted by the sponsor among the documents to be reviewed by the investigational review committee throughout the clinical trial period, and promptly submit all such documents to the head of the site when they are added, updated or revised (GCP Article 31, Paragraph 2, Guidance 3 Note 2).
On the other hand, there is no provision in GCP that requires submission of the study protocol, investigational new drug summary, etc. in Japanese to the site and the investigational review committee. However, in Japan, those involved in clinical trials are not necessarily fluent in English. Therefore, if the original documents are in English, the sponsor should prepare a Japanese version in advance or be ready to submit them promptly upon request from the site or the investigational review committee.
In light of the increasing number of international collaborative trials being conducted these days and the fact that the original documents used in such trials are in English, it is one way to enable prompt review by taking a flexible approach, such as using the original documents (in English) and materials specifying revisions (in Japanese) as a single set of materials for review by the Clinical Trial Review Committee. We believe that this is one way to enable prompt review. Some revisions of the relevant documents, such as those made to ensure the safety of subjects, should be reviewed as soon as possible, and it is important not to delay the review of such documents by waiting for the submission of the Japanese version.