Drug Evaluation Committee 2013-56 Incorporation of cases exceeding the number of contracted cases
Related classification: clinical trial contracting procedures
First published: March 2014
Question
In an ongoing clinical trial, the clinical trial contract states "Target number of subjects: 4 cases (as double-blind phase transition cases)". In this clinical trial, there is a pre-observation period of approximately 3 months, which is divided into 3 step periods. Then, the investigational drug (actual drug) is administered for the last 6 weeks of the observation period. In this case, if the condition is that the contract is added before the transition to the double-blind phase, is there any problem if the number of cases exceeds the number of contracted cases at the time of inclusion?
Opinion of the Pharmaceutical Cooperative Association
There is no problem with incorporating subjects into the observation phase beyond 4 cases (the number of contracted cases: as the transition to the double-blind phase). However, if a subject who has exceeded the contracted number of cases is unable to enter the double-blind phase due to contractual issues, it will be to the detriment of the subject.
In addition, due to the revision of GCP on December 28, 2012, the "target number of subjects" is no longer a mandatory item in the clinical trial agreement (revision of Article 13, Paragraph 1). In response to this, the necessity of stating the "target number of subjects" in a newly concluded clinical trial agreement and the response to changes in the target number of subjects in a clinical trial agreement already concluded before this revision will depend on the results of discussions between the site and the sponsor. Therefore, if there is some agreement between the two parties, it is not necessarily necessary to exchange a change agreement (including a memorandum of understanding) to change the number of subjects. If your hospital's SOP requires the conclusion of a memorandum of understanding regarding changes in the target number of subjects, we recommend that you consider revising the relevant sections.