Drug Evaluation Committee 2010-02 End of Provision of Safety Information by the Sponsor of a Clinical Trial (Part 2)
Related classification: clinical trial contracting procedures
First published: May 2010
Question
I am in charge of clinical leadership in Japan for an international clinical trial (24 countries participating) that is contracted collectively by our company, GLOBAL.
The clinical trial protocol states that "subjects who are discontinued due to SAE must be contacted one year after baseline to confirm the safety (of the items determined)". There are no regulations regarding testing or visits to the hospital during the period from discontinuation to one year later.
One of the sites was unable to complete the contracted number of cases and dropped out of the observation period, resulting in zero subjects receiving the investigational drug and only one case of discontinuation of the aforementioned SAE.
So my question is, in this case, if there is no problem on SOP, is there any problem without IRB procedures (e.g. safety report) which were conducted almost monthly?
I checked with the person in charge at Global (there are leaders like me in each of the 24 countries, and I am the coordinator of all the leaders and the clinical leader of this entire project), and he replied that if there is no problem with the SOP, there is no need for a safety report as long as the IRB agrees to it.
If there are no ongoing subjects, and there are only subjects who will be called one year after discontinuation to confirm the items that have been determined (i.e., discontinued cases, so their participation in the clinical trial has ended), is there any problem in Japan even if a safety report is not required (i.e., not discussed by the IRB)?
Also, if it is unnecessary, I would appreciate it if you could tell me if there are any actions that are not stipulated in the protocol but would be desirable to take before submitting the End of Study Report.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Basically, as stated in our opinion in response to question (8), "The sponsor should continue to provide safety information at least until the completion of administration and observation as stipulated in the protocol.
In this case, there are no subjects in the ongoing clinical trial at the site, and only the safety confirmation of the discontinued subject remains. If the sponsor has reached this conclusion in consideration of the safety profile of the investigational drug, and if the head of the site and the investigational review committee have given their approval, it would be acceptable in principle not to report safety information to both parties in the future. On the other hand, there may be safety information that needs to be communicated to the investigator and the subject after the investigational drug has been administered and discontinued, so it is necessary to at least notify the investigator of safety information that falls under GCP Article 20. In addition, some information on delayed adverse reactions may need to be reported to the site and the Clinical Trial Review Committee.