Drug Evaluation Committee 2015-41 Explanation to subjects regarding discontinuation of a clinical trial
Related classification: Obtaining consent
Date of first publication: 04/2016
Question
When the investigator decides to discontinue the clinical trial, it was assumed that the discontinuation of the clinical trial would be communicated to the subjects after the submission of the discontinuation report and the report to the Clinical Trial Review Committee. However, according to the sponsor's view, the opposite was communicated (communication of the discontinuation of the clinical trial to the subject → submission of a report on the discontinuation of the clinical trial). We would like to know what procedures we should follow if we decide to discontinue the trial.
Background
There have been concerns about the safety of the trial and the content of the trial plan, and the investigator is considering discontinuation of the trial at our hospital. If the investigator decides to discontinue the trial, there is a possibility that the investigator will be transferred to a different position in April, so we would like to report the discontinuation of the trial and apply for a change of investigator at the March Clinical Trial Review Committee meeting. If we need to explain the discontinuation of the clinical trial to the subjects, conduct an inspection at the time of discontinuation, and submit an Investigational Termination Report after the discontinuation report is made to the Clinical Trial Review Committee in March, it may take until April. At the time of discontinuation, there are about 5 subjects who are still in the clinical trial (medication, observation, etc. have not been completed).
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In making a decision to discontinue a clinical trial, the highest priority must be given to "protection of the human rights, maintenance of safety and improvement of welfare of subjects" (GCP Article 1 Guidance 2 (3)). Therefore, if the investigator decides that the clinical trial needs to be discontinued for safety or other reasons, it is important to promptly inform the subject and follow the discontinuation procedures stipulated in the protocol.
The procedure for discontinuation of a clinical trial stipulated in GCP requires the investigator to report promptly to the head of the site after discontinuation of the clinical trial (GCP Article 49, Paragraph 2), and the head of the site to promptly notify the Clinical Trial Review Committee and the sponsor (GCP Article 40, Paragraph 3).