Drug Evaluation Committee 2004-12 Pros and Cons of Direct Interviews with Subjects by Sponsors of Clinical Trials
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 with each other, but where exactly is this regulated by law?
JPMA's Opinion
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 Investigator Site to conduct the trial, and the investigators administer the necessary medication and tests to the subjects in accordance with the study protocol. If a subject has any questions regarding the clinical trial, the Investigator Site will respond to them.
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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, and Articles 13 and 51 of the GCP, as well as 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.If the sponsor interviews the subject directly during the clinical trial, there is a possibility that the subject's psychological state may be affected and the correct evaluation of the study drug may be impaired. In the case of compensation for health damage, the subject and the Investigator Site should first discuss the matter, and then the Investigator Site and the sponsor should discuss the matter. If the subject specifically requests a meeting with the sponsor, it is necessary to confirm the reason for the request and then decide on the best course of action.
Reason for revision
With the enforcement of the Pharmaceutical Affairs Law (November 25, 2014), we have made minor improvements to the description.