Drug Evaluation Committee 2008-51 Places to post advertisements for recruitment of test subjects
Related classification：Recruitment of human subjects
First published: Jul 2009
Revised publication date: Mar. 2021
Question
In general, advertisements for recruiting test subjects are posted in the hospital and in various media, etc. Is it possible to post a signboard of our own facility (in town, etc.) that is posted as a medical institution's advertisement if there is IRB approval for a clinical trial underway for the disease name?
Background
We have been asked if we can use the signage as part of the recruitment of subjects for clinical trials that we are contracted to conduct through our clinical trial network, which includes our clinic. We are considering asking the IRB to discuss the issue while also asking for the sponsor's opinion.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP does not specify the means of advertising for subject recruitment. However, advertising conducted mainly by medical institutions must comply with the Medical Care Act (including related regulations such as the "Guidelines for Medical Advertisements" (Medical Care Administration Announcement No. 0508-1, May 8, 2008)).
The advertisement for the recruitment of subjects for a specific clinical trial must be reviewed by the Clinical Trial Review Committee because it falls under Article 32, Paragraph 1, Item 2 of the GCP, "Materials related to procedures for the recruitment of subjects. The billboard advertisement outside the hospital that you are asking about would be possible if it complies with the above regulations and has the approval of the Clinical Trials Review Committee. However, unlike in the hospital, the advertisement will be seen by many members of the public, so it is necessary to be very careful about the content and wording of the advertisement, and if there are any changes in the content, the information should be revised promptly (it should be noted that the advertisement should not be left as "the trial is ongoing" after the trial ends). It is desirable to obtain the consent of the sponsor in advance when advertising.
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As of December 2023Advertisements led by the sponsor must comply with the Pharmaceuticals and Medical Devices Act (including related regulations such as Pharmaceutical Affairs Bureau No. 65, June 30, 1999, "Handling of Information Provision for Recruitment of Test Subjects for Clinical Trials").
Reason for revision of opinion
The description has been revised in accordance with the revision of the Pharmaceuticals and Medical Devices Act and the "Guidelines for Medical Advertisements".