Drug Evaluation Committee 2017-04 Description of the results of the interim analysis of the study in the revised version of the explanatory document
Related classification: Obtaining consent
Date of first publication: June 2017
Question
A single-arm, open-label study of the actual drug is being conducted in the Department of Pediatrics at our hospital. With this revision of the explanatory document for subjects, the results of the interim analysis have been added. The interim analysis results show that the drug is effective to this extent, but is it acceptable to include the efficacy of the interim analysis in the explanatory document for subjects? By including the statement, "It is effective," is the patient's intention to continue the treatment being guided in the direction of continuing the treatment?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The explanatory document to the subject (in this case, the surrogate) must include the anticipated benefits of the investigational drug on the subject's mental and physical health (if no such benefits are anticipated, a statement to that effect) and the anticipated disadvantages to the subject (GCP Article 51, Paragraph 1, Item 5). In addition, if information is obtained during the course of a clinical trial that may influence the subject's intention, the investigator must promptly revise the explanatory document and obtain the consent of the subjects already participating in the clinical trial to continue participating in the trial (GCP Article 54).
On the other hand, when preparing (revising) the explanatory document, sufficient care must be taken to ensure that information on the efficacy of the investigational drug is described in a manner that does not give preconceived notions that may influence the subject's willingness to participate in the clinical trial. Therefore, based on the position and results of the interim analysis, we recommend that you consider the necessity of revising the explanatory document from the perspective of both the subject's right to know and its impact on the subject's willingness to continue the trial, and if necessary, make a question-and-answer inquiry to the sponsor. At that time, it is also recommended to confirm with the sponsor whether or not there is a disparity in the information available to subjects between sites.