Drug Evaluation Committee 2005-08 Street Distribution of Advertisements for the Recruitment of Human Subjects
Related classification: subject recruitment
Initial release date: May 2006
Revised publication date: December 2021
Question
Regarding the method of providing information on the recruitment of test subjects, the Japan Pharmaceutical Manufacturers Association states in its document "Guidelines for Providing Information for the Recruitment of Test Subjects for Clinical Trials (Revised Version), November 2008" that "1. Method of providing information: Many information transmission media such as posters, newspapers, magazines, flyers, television, radio, and Internet homepages can be used. However, it is possible to use flyers by force.
However, they must not be coercive, such as forcibly handing out flyers. Is it acceptable to hand out leaflets to each person individually (not forcibly), such as distributing leaflets on the street?
JPMA's Opinion
In accordance with "Regarding the Applicability of Advertisements of Drugs, etc. under the Pharmaceutical Affairs Law (Pharmaceutical Affairs Bureau No. 148 of September 29, 1998)" and "Regarding the Handling of Information Provision for the Recruitment of Subjects for Clinical Trials (Pharmaceutical Affairs Bureau No. 65 of June 30, 1999, Pharmaceutical Affairs Bureau ASP No. 50 of January 31, 2001, and Pharmaceutical and Food Safety Bureau Monitoring Guidance and Drug Control Division Office Communication of July 27, 2007)". In accordance with the "Drugs and Narcotics Control Division, Pharmaceuticals and Food Safety Bureau (No. 65, June 30, 1999; No. 50, January 31, 2001; July 27, 2007)," there should be no problem as long as the information provided is not exaggerated or misleading and leaflets are not compulsorily distributed.
In addition, in accordance with GCP Article 32, Paragraph 1, Item 2) "Materials on Procedures for the Recruitment of Subjects," it is necessary to obtain the opinion of the Clinical Trial Review Committee regarding the method of providing information on the recruitment of subjects, and this is subject to deliberation.
Reason for revision
The description of Notification, etc. was reviewed.