Serious adverse event
A serious adverse event (SAE) (from English serious adverse events , SAE ) is a fatal incident, in the context of a clinical trial with drugs or medical devices in a patient or test persons occurs.
Legal requirements
According to the GCP regulation and the German Medicines Act or Medical Devices Act , all adverse events are considered serious if:
- result in the death of a subject,
- are immediately life-threatening,
- necessitate an unforeseen hospital stay or the extension of a hospital stay,
- result in a congenital abnormality or a birth defect, or
- result in permanent or serious disability or disability .
Initially, it does not matter whether the SAE is causally related to the study or not; The only decisive factor is the temporal connection.
If an SAE occurs, the investigator must immediately notify the sponsor of the study. If there is a suspicion of a causal relationship with the test substance or the test method and the event cannot be classified as expected, the sponsor of the study is obliged to inform all responsible health authorities and all responsible ethics committees as well as the department responsible for pharmacovigilance of the relevant manufacturer of to inform the SAE. In addition, the GCP regulation also requires detailed documentation of the SAE.
Known Serious Adverse Events
On 17 September 1999 passed a test subject, who in congenital ornithine - transcarbamylase suffered deficiency, while trying his hereditary disease by transferring a healthy ornithine transcarbamylase gene by an adenovirus - vector heal, to massive immune failure. The immune failure was caused by the adenovirus, which served as a gene ferry.
On March 13, 2006, six previously healthy volunteers became critically ill after being administered the test substance TGN1412 , which had previously been classified as harmless, as part of a drug study .
On January 15, 2016, a patient died from the drug BIA 10-2474 , an inhibitor of the fatty acid amide hydrolase FAAH, made by the Portuguese pharmaceutical company BIAL . Death occurred in the clinical dose determination phase ( phase 1 study ) when the healthy test person and five other volunteer subjects received the maximum intended dose. According to the clinic, four subjects suffer from bleeding and necrosis of varying severity in the central nervous system . The sixth person is under observation.
See also
literature
- Manfred Stapff: drug studies. A manual for conducting clinical trials specifically for physicians and medical assistants. W. Zuckschwerdt Verlag GmbH, Munich, 2007. ISBN 978-3-88603-912-8
Web links
- Text of the Medicines Act (Germany)
- Text of the GCP regulation (Germany)
- Food and Drug Administration (FDA) definition