Drug Evaluation Committee 2012-36 Notification of participation in clinical trials to other attending physicians (other hospitals)
Related classification: Other
Date of first publication: December 2012
Question
A patient who regularly visits another hospital every six months for follow-up after thyroid surgery was enrolled in a clinical trial for inpatients. The investigator determined that contacting the other hospital was not necessary because the patient is an inpatient and can manage concomitant medications, etc. during the trial period.
The GCP Guidance states, "The purpose of Paragraph (2) of Article 45 is to prevent adverse effects on the subject's health due to interactions with drugs already administered in the treatment the subject is receiving. Therefore, it seems that if the clinical trial is conducted on inpatients, the purpose is satisfied even without contacting other hospitals. On the other hand, GCP also states that the attending physician must be informed about the participation in the clinical trial, which could be taken to mean that the attending physician must be notified when another attending physician is present.
If the study involves inpatients and it is clear that they will not see other attending physicians during the trial period, please give us your opinion on the necessity of contacting other hospitals.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 45, Paragraph 2 of the GCP stipulates that "If the subject is being treated by another physician, the investigator must, with the subject's consent, notify that other physician of the subject's participation in the clinical trial." This is the purpose of Article 45, Section 2 of the GCP. The purpose of this provision is, as stated in Article 45, Paragraph 2, Guidance 1 of the GCP, "to prevent health hazards to the subject due to interactions with drugs, etc. already administered in the treatment the subject is undergoing. Therefore, if there is a possibility that another treatment will be given by a physician from another hospital or department during the clinical trial period, it is necessary to notify the subject by some means.
Therefore, if an inpatient goes to another hospital during a clinical trial and there is a possibility that he/she will receive some kind of treatment at the other hospital, it is necessary to notify the other hospital.