Drug Evaluation Committee 2014-33 Advertisement for recruitment of test subjects in patient groups (Part 2)
Related classification: subject recruitment
Date of first publication: December 2014
Question
In relation to question No. 2009-58, "Recruitment of human subjects advertising at patient groups," is it acceptable to provide information on recruitment of human subjects using information media (newsletters, booklets, websites, SNS, etc.) created and managed by patient groups in addition to flyers advertising clinical trials? If so, please advise us of any points to keep in mind.
Is it possible to report the information later under the investigator's name?
JPMA's Opinion
We believe that there will be no problem if you provide information for the purpose of recruiting subjects using information media created and managed by patient groups, as long as you follow the "Guidelines for Providing Information for the Recruitment of Subjects for Clinical Trials (revised version)" published on the JPMA's website.
Since the information you are planning to provide is for the purpose of recruiting subjects, it must be approved by each Investigational Review Committee as "materials related to procedures for recruiting subjects (advertising, etc.)" (GCP Article 32, Paragraphs 1 and 2, Guidance 2 (3)). In addition, when providing information on the name of the investigational institution, investigator, or department, this information must also be reviewed by the investigational review committee and approved by the Chairperson of the investigational institution. In addition, we ask that you consider in advance how to respond to inquiries regarding the provision of information, and if you incur costs with the sponsor for the use of information media prepared and managed by the patient organization, and if such costs constitute funding or support for the patient organization, please contact the JPMA website for more information. If you are using information media created and managed by a patient organization, and if there is a cost between you and the sponsor that constitutes funding or support for the patient organization, please follow the "Transparency Guideline for the Relationship between Corporate Activities and Patient Organizations," which is available on our website.