Drug Evaluation Committee 2022-57 The sponsor's opinion on safety information in double-blind studies
Related classification: Adverse drug reaction reports
Date of first publication: Apr 2024
Question.
There is one sponsor that does not state the sponsor's opinion on the "Adverse Reaction Case Form for Investigational New Drug" of the Corporate Clinical Trials and Safety Information, stating "The double-blind study is ongoing, so we are maintaining the blinded status. and there is one sponsor that does not state the sponsor's opinion.The other sponsor stated the sponsor's opinion as if the drug was actual drug even in the double-blind study.
From the viewpoint of subject protection, we believe that the sponsor's opinion should be expressed for the safe conduct of a clinical trial, but only stating "We maintain blindedness." However, I feel that the sponsor is irresponsible if it only states "We are maintaining blindness.
I have repeatedly told this to the sponsor, but have not received a satisfactory response.
We would like to ask your committee's opinion.
The view of the Pharmaceuticals Association of Japan
I will answer your question on the assumption that the "Investigational New Drug Adverse Reaction Case Form" is the "Investigational New Drug Adverse Reaction/Infectious Disease Case Form" in a double-blind study.The "Investigational New Drug Adverse Reaction/Infectious Disease Case Form" is a report on individual adverse drug reaction cases submitted by the sponsor to the Ministry of Health, Labour and Welfare. As you stated in your question, we believe that many companies would include the sponsor's opinion as if the drug were an actual drug, even in a double-blind study. However, the way the case form for the individual adverse reaction report is written differs for each sponsor, and the Pharmaceutical Manufacturers Association cannot uniformly provide an opinion.
The sponsor has the responsibility to continuously evaluate the safety of the investigational drug. In double-blind studies, it is difficult to evaluate the causal relationship of individual adverse reactions under blinded conditions, but even in such cases, the sponsor follows internal procedures to evaluate individual adverse drug reaction cases and accumulated information, and continuously monitors the safety of the study (by establishing a data monitoring committee, etc.), (Some sponsors have established a data monitoring committee to evaluate and monitor the data).
When information that may affect the safety of subjects or the safe conduct of a clinical trial is suggested, it is communicated to the investigator by means of an urgent letter to the principal investigator or action report. Therefore, it is possible to confirm the sponsor's opinion on the safety profile of the investigational drug and information that affects the safety measures of the clinical trial by these means (or information).