Drug Evaluation Committee 2010-33 Confirmation of Intention to Continue a Clinical Trial Following Revision of Explanatory Documents (Part 3)
Related classification: Obtaining consent
First published: November 2010
Question
When survival rate or survival time is an endpoint in a clinical trial of an anti-cancer drug, the survival study period after completion of the administration of the investigational drug may range from about one year to several years, depending on the carcinoma/patient. Please explain the need to obtain re-consent for the revision of the Explanatory Document (ICF) for subjects during the survival study period after the end of drug administration, when no blood sampling or tests are performed to confirm the subject's survival.
If the survival study period after the administration of the investigational drug is included in the clinical trial period, then it is necessary to promptly provide information to subjects and obtain their re-consent with the revised ICF in accordance with Article 54, Paragraphs 2 and 3 of the GCP. However, for subjects who have completed the administration of the investigational drug and entered the survival study period, we believe that it is necessary to provide information to them, but we question whether it is necessary to obtain their re-consent.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The re-consent stipulated in Article 54 of the GCP is to confirm "whether or not the subject will continue to participate in the clinical trial," and when the explanatory document is revised due to "information deemed to influence the subject's intention," it is usually necessary to obtain re-consent in writing from the subject still participating in the clinical trial using the revised explanatory document. However, Question No. (2007-23) (2) is not applicable. However, as indicated in the opinion in question No. ( 2007-23 ), if the administration of the investigational drug and examination/observation have been completed and only the survival study remains, re-consent would not be required unless the amendment of the explanatory document is due to a change in the method of the study.