Drug Evaluation Committee 2012-17 Release of the names of medical institutions in public information of clinical trials
Related classification：Recruitment of human subjects
Initial release date: 2012.08
Revised release date: Mar. 2021
Question
Question 1
The publication of the names of investigational sites in clinical trial databases such as Clinical Trial.gov and jRCT does not fall under the "Guidelines for Providing Information for the Recruitment of Subjects for Clinical Trials" published by the Pharmaceutical Manufacturers Association of Japan in November 2008, because the purpose is to provide information, not to recruit subjects. Is it correct to conclude that this is not applicable?
Question 2
We are planning to publish an outline of the clinical trial (purpose, planned acceptance period, main criteria for participation, method and duration of the trial, etc.) on the company website (hereinafter referred to as "website"). In this case, we would like to post links to Clinical Trial.gov, jRCT, etc. on our website.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Registration of clinical trials with the U.S. NIH's Clinical Trial.gov, the Japan Registry of Clinical Trials (jRCT), etc. (hereafter referred to as Clinical Trial.gov, etc.) are conducted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the U.S. The registration of clinical trials in the Japan Registry of Clinical Trials (hereinafter referred to as "Japan Registry of Clinical Trials") and other databases such as Clinical Trial.gov (hereinafter referred to as "Clinical Trial.gov") is conducted by the IFPMA, PhRMA, EFPIA, and JPMA as part of a joint statement entitled "Joint Guidelines for Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases" to provide information on clinical trials to the general public. The JPMA is implementing these guidelines in the form of a joint statement to inform the public about clinical trials. On the other hand, the recruitment of subjects for clinical trials is mainly for the purpose of recruiting subjects by the medical institution conducting the relevant clinical trial, which is different from the purpose of disclosing information on clinical trials. In addition, posting a link to Clinical Trial.gov, etc. on the company website is considered part of the disclosure of information on clinical trials. Therefore, posting the name of the institution conducting the clinical trial on Clinical Trial.gov, etc. and posting a link to Clinical Trial.gov, etc. on the company website do not constitute "providing information for recruiting subjects" as defined in the Pharmaceutical Manufacturers Association of Japan's "Guidelines for Providing Information for the Recruitment of Subjects for Clinical Trials". However, it is not considered to be "information for recruiting subjects" as defined by the Pharmaceutical Manufacturers Association of Japan.
However, if the name of the medical institution conducting the clinical trial is posted as clinical trial information, it is expected that inquiries, etc., will be made directly to the medical institution by the viewer.
Reason for revision of opinion
In accordance with the issuance of "No. 0831 No. 9 of August 31, 2020, "Registration of Clinical Trial Implementation Status" by the Pharmaceutical Affairs Agency, minor changes were made to the description.