Drug Evaluation Committee (2) Entry of foreign subjects
Related classification: Other
First published: December 2004
Question
I would like to know about the pros and cons of entry for foreign nationals.... At least, the study protocols commissioned by our hospital do not state the pros and cons of such entry. However, there was one that had a check for Mongolian race in the CRF from the beginning. I believe that each drug may or may not have problems with metabolic enzymes, etc. Is it mentioned in the protocol only if there is a problem, or is it unconditionally NG or OK? Personally, I think it is undesirable, but probably not mentioned anywhere. I think that entering a foreigner would be tantamount to unconditionally accepting foreign data and ignoring the bridging test. However, I think that the term "foreigner" is also vague and cannot be said only in terms of nationality. It is more accurate to say by race, but I think that identification can also be difficult. There is also the issue of generation.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If there is no restriction in the study protocol (hereafter referred to as "study protocol"), it is acceptable to treat the entry of foreigners into the study as "acceptable (no problem)" as long as the study does not intentionally target only foreigners (not far from the composition of the Japanese resident population). In this case, however, the subject should not be asked to participate in the study. In this case, however, it is necessary to obtain appropriate informed consent by means of an explanatory document in a language understandable to the subject.
In most cases, there are no measures to avoid entry of non-Japanese subjects in clinical trials conducted in Japan, specifically, no selection or exclusion criteria for subjects with respect to race or ethnicity. This is because 1) "the necessity of Japanese subjects" is not clearly indicated in the regulations for clinical trials conducted in Japan for the purpose of collecting data for regulatory submission, and 2) clinical trial results conducted in Japan are uniformly evaluated for efficacy and safety in Japan (human) as long as they are collected and prepared in compliance with GCP and meet reliability criteria. (2) Clinical trial results conducted in Japan are accepted as data for the evaluation of efficacy and safety in Japan (human) as long as they are collected and prepared in compliance with GCP and conform to the reliability criteria.
On the other hand, there are cases in which race or ethnicity must be specified as a subject selection/exclusion criterion in the protocol, such as: 1) when data are obtained that predict risks specific to race or ethnicity (as a risk avoidance measure), and 2) in pharmacokinetic studies.
The practice of not requiring race or ethnicity in the selection of subjects, but requiring that race or ethnicity be included in the case report form, seems to be widely used in 1) multinational clinical trials, 2) multinational trials (multinational trials with the same protocol, which are expected to be conducted increasingly in the future), and other such cases. The same protocol is expected to be used in an increasing number of multinational trials in the future.