Drug Evaluation Committee 2018-07 Adverse Event Evaluation of Test Results Determined Not to be Clinically Meaningful
Related classification: Report of adverse drug reactions, etc.
Date of first publication: June 2018
Question
A subject currently participating in a clinical trial was determined to have an "Abnormal" ECG as a result of an automated determination of the ECG. The physician's opinion on the result was "Not clinically significant," but it was reported as an adverse event.
I confirmed with the physician that "all events should be collected regardless of causality, otherwise it is impossible to collect all adverse events," and the report has been raised as an adverse event even though it is not clinically significant. I have re-read the GCP, but cannot find it.
JPMA's Opinion
In the "Handling of Safety Information Obtained During Clinical Trials (March 20, 1995, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, No. 227)," adverse events are defined as follows.
An adverse event is defined as "any unfavorable medical event that occurs in a patient or subject to whom a drug product has been administered, and that is not necessarily causally related to the administration of the drug product. It does not necessarily indicate only those events that have a clear causal relationship to the administration of the drug. In other words, an adverse event is any unwanted or unintended symptom, condition, or disease that occurs when a drug is administered, regardless of whether or not it is causally related to the drug.
In clinical trials, adverse events are evaluated by investigators in accordance with the study protocol, and in general, adverse events are defined as clinically significant abnormal findings, abnormal values, or abnormal fluctuations in the results of tests such as electrocardiograms. The evaluation of adverse events is performed in accordance with the study protocol. These evaluations should be made comprehensively based on the provisions of the study protocol and medical judgment.
Please also refer to JPMA's recommendation document "Recommendations on the Collection and Reporting of Safety Data (October 2009)".