Drug Evaluation Committee 2010-09 Necessity of Review by Clinical Trial Review Committees for the Use of Public Awareness Materials for Clinical Trials
Related classification: Clinical Trial Review Committee
Date of first publication: June 2010
Question
Do pamphlets and posters published by the Center for Clinical Trial Promotion of the Japan Medical Association and the JPMA for the general public need the approval of a Clinical Trial Review Committee if they are used to recruit or explain about clinical trials?
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.
JPMA's Opinion
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.
Article 32, Paragraph 1 of the GCP stipulates that the materials for the investigational review committee to give its opinion to the Chairperson of the site include "materials on procedures for recruiting subjects," but we believe that these materials are for recruiting subjects for the clinical trial and contain information specific to each clinical trial, such as the target disease, name of the investigator, and name of the 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 Center for Clinical Trial Promotion of the Japan Medical Association (JMA) and the JPMA do not contain information specific to individual clinical trials and do not require review by the Clinical Trial Review Committee.