Drug Evaluation Committee 2018-59 Change of Clinical Trial Sponsor due to Transfer of New Drug Development Rights
Related classification: Clinical Trial Review Committee
First published: Mar 2019
Question
Please tell us what to do if the sponsor changes during a clinical trial. The investigational drug is a drug developed by the current sponsor, A. Last year, Company B acquired Company A and decided to relinquish the investigational drug under development. Company C was established to continue development, and Company A has decided to transfer ownership and development rights of the investigational drug to Company C to continue development of the drug.
Our hospital is thinking of having the Clinical Trial Review Committee review a letter describing this process in the change application and the revised clinical trial protocol, and after approval, reviewing the revised explanatory documents and other documents for subjects. Is it possible to review these at the same time? Please tell us how we should go about this and whether there are any GCP issues.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
With a change of sponsor, it is necessary to change the name of the sponsor for the documents that were reviewed by the investigational review committee prior to the start of the clinical trial, such as the protocol and explanatory documents to subjects. The change of the sponsor must be notified to the Trial Review Committee, but the review is not mandatory.
However, if the head of the medical institution recognizes that the change in the sponsor will affect the conduct of the clinical trial and increase the risk to the subjects, a review by the Investigational Review Committee is required (GCP Article 31, Paragraph 2, Guidance 3).
There is no problem if a change in the sponsor and a related revision of the study protocol and other documents are reviewed at the same time.