Drug Evaluation Committee 2022-57: Sponsor’s Opinion on Safety Information from a Double-Blind Trial
Related Category: Adverse Event Reports
Initial Publication Date: April 2024
Question
In the “Investigational Drug Adverse Event Report Form” for corporate clinical trials and safety information, one sponsor has stated, “Blinding is being maintained because the double-blind trial is ongoing,” without explicitly expressing the sponsor’s opinion.Other sponsors, even in double-blind trials, include their opinion stating that the treatment is the active drug.
From the perspective of subject protection, I believe that to ensure the safe conduct of a clinical trial, the sponsor’s opinion should be stated; however, I feel that simply stating “We are maintaining blinding” is irresponsible on the part of the sponsor.
I have repeatedly conveyed this point to the sponsor, but have not received a satisfactory response.
I would like to request your committee’s opinion on this matter.
JPMA Opinion
We will respond on the assumption that the “Investigational Drug Adverse Event Case Report Form” mentioned in your question refers to the “Investigational Drug Adverse Event and Infection Case Report Form” used in double-blind trials.The “Investigational Drug Adverse Event and Infection Case Report Form” is a report on individual adverse event cases submitted by the sponsor to the Ministry of Health, Labor and Welfare.As you noted in your inquiry, while we believe many companies do include the sponsor’s opinion that the drug was the active treatment even in double-blind trials, the method of completing individual adverse event report forms varies by sponsor, and the JPMA cannot issue a uniform opinion on this matter.
The sponsor is responsible for continuously evaluating the safety of the investigational drug.While it is difficult to assess the causality of individual adverse events under double-blind conditions, even in such cases, sponsors evaluate individual adverse event case reports and aggregated data in accordance with their internal procedures and continuously monitor the trial to ensure it is conducted safely (some sponsors establish Data Monitoring Committees or similar bodies to conduct these evaluations and monitoring).
If information suggesting a potential impact on subject safety or the safe conduct of the clinical trial is identified, it is required to be communicated to the clinical trial site via an urgent letter to the principal investigator or an adverse event report; therefore,we believe that the sponsor’s views regarding information affecting the investigational drug’s safety profile and clinical trial safety measures can be confirmed through these communication channels (or the information they contain).