Drug Evaluation Committee 2015-33 Indication of the name of the abbreviated study in the recruitment of test subjects
Related classification：Recruitment of human subjects
Date of first publication: February 2016
Question
Please provide information on the "Guidelines for the Provision of Information for the Recruitment of Subjects for Clinical Trials - Revised Edition (November 2008, Japan Pharmaceutical Manufacturers Association)".
(1) Regarding the recruitment of subjects for clinical trials via the Internet or SNS, etc., there are regulations in the Pharmaceutical Affairs Law that prohibit the promotion of unapproved drugs, and the generic names of investigational drug components and development numbers cannot be included in the recruitment content. In order to be able to identify the sponsor's clinical trial, we would like to indicate "Nickname of the trial-specific study: XXX study" in the Internet recruitment contents.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
According to the Ministry of Health and Welfare, Pharmaceutical Safety Bureau, Surveillance and Guidance Division, Director's Notification, Pharmaceutical Affairs Bureau, No. 65, "Handling of Information Provision for Recruitment of Subjects for Clinical Trials" (June 30, 1999), "Information provision for recruiting subjects for conducting a clinical trial, which does not indicate the name of the investigational drug or the trial symbol, is not considered as an advertisement. The "name of the study specific to the clinical trial" in question is "Nickname of the study".
If the "trial-specific study nickname" in your question does not contain information that could be considered an advertisement for an unapproved drug, we believe that it is acceptable to clearly state this in the recruitment content. In addition, there is no problem in disclosing "the name of the sponsor" and "the name of the subject disease" as part of the information provided when recruiting subjects, so it should be possible for medical institutions to identify the clinical trial from which subjects inquire using this information.
For other points to be noted, we recommend that you refer to the "Guidelines for Providing Information for Subject Recruitment for Clinical Trials - Revised Edition" and fully discuss them with the medical institution conducting the clinical trial.