Drug Evaluation Committee 2010-09 Necessity of Review by Clinical Trial Review Committee for Use of Public Awareness Materials for Clinical Trials
Related classification: Clinical Trial Review Committee
First published: Jun 2010
Question
Do pamphlets and posters published by the Center for Clinical Trial Promotion of the Japan Medical Association and the Pharmaceutical Manufacturers Association of Japan need the approval of a Clinical Trial Review Committee if they are used to recruit or explain about clinical trials to the general public?
I thought that they do not constitute advertisements for the recruitment of subjects, but rather materials to widely publicize the clinical trial to the general public. I know this may sound basic, but I would appreciate your opinion.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Brochures and posters for the general public and patients are not prepared for the purpose of providing information about a specific clinical trial or recruiting subjects, but are provided for the purpose of spreading awareness of the clinical trial. Therefore, we do not believe that such pamphlets, etc. need to be reviewed by the Clinical Trial Review Committee.
In Article 32, Paragraph 1 of the GCP, there are "materials on procedures for recruiting subjects" as materials for the investigational review committee to give its opinion to the head of the implementing medical institution, but these materials are for recruiting subjects for the clinical trial and should contain information specific to each clinical trial, such as the target disease, name of the principal investigator, and department. We believe that these materials are for the purpose of recruiting subjects for clinical trials.
Therefore, we believe that the pamphlets and posters for clinical trial promotion by the Japan Medical Association Clinical Trial Promotion Center and the Pharmaceutical Manufacturers Association of Japan do not contain information specific to individual clinical trials and do not require the review of the Clinical Trial Review Committee.