Drug Evaluation Committee 2018-07 Adverse Event Evaluation of Test Results Determined Not to be Clinically Meaningful
Related classification: Adverse drug reaction reports
Date of first publication: June 2018
Question
The results of an automated EKG evaluation of a subject currently participating in a clinical trial were determined to be "Abnormal". The physician's opinion of 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 would not be possible 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.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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 the Pharmaceutical Manufacturers Association of Japan (PMAJ) recommendation document "Recommendations on the Collection and Reporting of Safety Data (October 2009)".