Drug Evaluation Committee 2017-33 Conducting Additional Investigation after Clinical Trial Completion
Related classification: Other
Date of first publication: October 2017
Question
Background
For a clinical trial that had been conducted until May 2017, an additional investigation was requested on a subject three months after the end of the investigational drug administration for PMDA inquiry matters.
The investigator's view was that although the clinical trial had ended, he wanted to conduct the investigation after requesting a review by the Clinical Trial Review Committee and asking for their opinion, considering the ethical aspects of the subject. Thus, in the case of review by the Clinical Trial Review Committee, is it correct to take the procedure for resumption of the clinical trial and then conduct the review? However, the term of the clinical trial contract is until May 31, 2017, and I believe that the contract needs to be extended when the trial is resumed.
However, the sponsor's view is that they would like us to consider this as a new investigation and separate it from the clinical trial, rather than reopening the clinical trial.
Question
In such a case, what procedures are necessary for requesting a review by the Investigational Review Committee?
Or is a review by the Clinical Trials Review Committee unnecessary?
JPMA's Opinion
We believe that there is no problem in deciding between the site and the sponsor as to whether or not a contract is required for this additional investigation and the form of the contract (change of the original clinical trial contract/new outsourcing contract).
Also, we think it is acceptable for the Chairperson of the site to determine the necessity of review by the Clinical Trial Review Committee based on the contents and methods of the additional investigation. When reviewing, the appropriateness of the content of the additional investigation, the method of the additional investigation, and the necessity of obtaining consent from the subject, etc. may be reviewed.