Drug Evaluation Committee 2013-40 Clinical Trial Participation Card and Information Provision to Other Medical Institutions
Related classification: Other
First published: December 2013
Question
This is a question regarding the "Clinical Trial Participation Card.
A subject is a person who has consented and is currently participating in a clinical trial. The CRC gave him a clinical trial participation card after explaining about the trial, and he said the following It is fine to show the name of the prohibited drugs to other medical institutions, but the name and content of the clinical trial in which I am participating may be leaked by someone at another medical institution where I will be seen. This may be inconsistent with the protection of privacy stated in the consent form." He said, "I have to present my clinical trial participation card to the other medical institutions. He said that presenting his clinical trial participation card to other medical institutions would disclose the name of his disease, the details of his treatment, and the fact that he was participating in a clinical trial, and that this would not protect his privacy.
If you do not present your clinical trial participation card when you visit other medical institutions, you may be expected to use drugs that are banned for concomitant use, or to suffer health problems. We would like to know how to respond to the subject in this case and what to do if the subject does not present the clinical trial participation card.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In a clinical trial using an unapproved drug, the main principle is to conduct the trial under a sufficient system to ensure the safety of the subjects.
In this regard, the investigator, etc. must notify the other physicians concerned of the subject's participation in the clinical trial with the subject's consent, based on Article 45, Paragraph 2 of the GCP Ministerial Ordinance, "The investigator shall notify the other physicians concerned of the subject's participation in the clinical trial." In order to prevent adverse effects on the subject's health due to interactions with investigational drugs, etc., it is necessary to provide information on concomitantly prohibited drugs, etc., in accordance with Article 45, Paragraph 2 of the GCP Ministerial Ordinance.
It is important to fully explain the significance of this information disclosure to the subject and obtain his/her understanding, but if the subject does not give his/her consent, it would be inevitable to withdraw his/her participation in the clinical trial from the perspective of ensuring the subject's safety and compliance with GCP.
In light of the above, it is necessary to discuss with the sponsor and decide how to respond to the situation.