Drug Evaluation Committee 2010-50 Change in Methods of Conducting Clinical Trials by Letter from the Sponsor
Related classification: clinical trial contracting procedures
Date of first publication: Apr. 2011
Question
After the start of a clinical trial, we received a letter from the sponsor informing us of the addition of an item that falls under the selection and exclusion criteria not described in the protocol (one of the clinical test items must be within the range determined by the sponsor or medication cannot be administered). The sponsor did not change the study protocol, but responded only with a letter to the principal investigator, and only the letter was discussed at the Clinical Trial Review Committee. We were told that the letter is positioned as the same as the protocol, but is it possible to respond only with the letter without revising the protocol?
If the letter alone is acceptable, is the investigator's agreement required for the letter since it is positioned as the same as the study protocol?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If the content of the additional communication you are asking about is the addition of selection criteria and exclusion criteria, then we need to revise the study protocol in accordance with GCP. It is necessary to obtain the investigator's agreement to the change in writing (GCP Article 7, Paragraph 4), and the Investigational Review Committee must review whether the change is ethically and scientifically appropriate (GCP Article 31, Paragraph 2). On the other hand, if it is a supplemental explanation to the items stipulated in the protocol, it is possible to provide a letter to the investigators for the purpose of making them aware of the protocol.
When revising the protocol, it is not necessary to prepare a version that reflects all changes. If the revisions are clear and the procedures described above are followed, there should be no problem in preparing only a document describing only the changes.