Drug Evaluation Committee 2009-58 Advertisement for recruitment of test subjects in patient groups
Related classification：Recruitment of human subjects
First published: April 2010
Question
In the clinical trial for which I am currently in charge, I would like to distribute flyers advertising the clinical trial to patient groups (to be placed at their offices, etc.) for the purpose of recruiting test subjects for the disease targeted in the clinical trial.
In such a case, is it acceptable for the sponsor to approach the patient groups directly?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
There is no problem for the sponsor to distribute clinical trial advertising flyers directly to patient groups. However, the name of the site, investigator, and department must be reviewed by the Clinical Trial Review Committee, approved by the head of the site, and the site must be able to respond to inquiries.
Please refer to the "Guidelines for Providing Information for the Recruitment of Subjects for Clinical Trials (Revised Version)" and "Question No. 2008-51: Where to Post Advertisements for the Recruitment of Subjects", etc., which are available on the website of the Pharmaceutical Manufacturers Association of Japan (PMAJ).