Drug Evaluation Committee 2004-12 Pros and Cons of Direct Interviews with Subjects by the Sponsor of a Clinical Trial
Related classification: Other
First published: December 2004
Revised publication date: March 2021
Question
We have a question related to GCP, etc. I believe that the sponsor and subjects are not allowed to meet directly, but where exactly is this regulated by law?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
There are no provisions in the GCP ordinance or other related regulations that explicitly prohibit the sponsor from meeting directly with the subject:
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1.As you know, in a clinical trial system, the sponsor requests the medical institution to conduct the trial, and the investigator administers the necessary medication and tests to the subject in accordance with the study protocol. If there are any questions from subjects regarding the clinical trial, the investigator is expected to respond to them at the site.
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2.Various regulations have been established to protect the privacy of subjects, including Article 80-2, Paragraph 10 of the Pharmaceutical Affairs Law, Articles 13 and 51 of the GCP, and penalties (Article 86-3, Paragraph 1, Item 11 of the Pharmaceutical Affairs Law). Direct access to medical records by the sponsor is also handled in compliance with these regulations. A direct interview between the sponsor and the subject is considered to be a more in-depth situation regarding the subject's privacy than a direct inspection, and is therefore usually not allowed.
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3.Direct interview by the sponsor with the subject during a clinical trial may, in some cases, affect the subject's state of mind and impair the correct evaluation of the study drug. In the case of compensation for health damage, it is considered normal to first have a discussion between the subject and the site, and then the site and the sponsor. If the subject specifically requests a meeting with the sponsor, it is necessary to confirm the reason for the request and decide on the best course of action.
Reason for revision of opinion
With the enforcement of the Pharmaceutical Affairs Act (November 25, 2014), minor changes were made to the description.