The Ministry of Food and Drug Safety issued a warning to two clinical research organizations (CRO) for late reporting of adverse drug events. The two are Pharmaceutical Product Development (PPD) and ICON Clinical Research.
PPD was conducting a trial to test immunotherapy called “ONO-4538,” and ICON Clinical Research, a treatment for B cell lymphoma “MOR00208.” Both received the warning because of the delay of reporting significant and unexpected adverse events during the clinical trials.
The Pharmaceutical Affairs Act stipulates that in the case of a severe and unexpected adverse drug reaction, a test client must promptly report it to the study subjects, the food and drug safety minister, and the clinical trial assessment committee.
If the event caused death or was life-threatening, the client must report it to the authorities within seven days of learning it.
If the adverse event report did not include full information such as the name of the adverse drug reaction, the final observation result, or adverse drug reaction summary, the client should report additional details within 15 days from the date of learning it.
Besides, a test client must report a severe and unexpected adverse drug reaction to the authorities within 15 days of learning it.
If there is additional information on the reported adverse drug reaction, the client should report it until the adverse drug reaction disappears or until the follow-up investigation becomes impossible.
<© Korea Biomedical Review, All rights reserved.>