In
drug development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regu ...
, serious adverse event (SAE) is defined as any untoward medical occurrence during a human
drug trial that at any dose
# Results in death
# Is life-threatening
# Requires inpatient
hospitalization or causes prolongation of existing hospitalization
# Results in persistent or significant disability/incapacity
# May have caused a congenital anomaly/birth defect
# Requires intervention to prevent permanent impairment or damage
The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.
Adverse event
In pharmaceuticals, an adverse event (AE) is any unexpected or harmful medical occurrence that happens to a patient during medical treatment or a clinical trial. Unlike direct side effects, an adverse event does not necessarily mean the medicati ...
s are more broadly defined by international regulation as “Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.”
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]
Research
Investigators in human clinical trials are obligated to report these events in clinical study reports. Research suggests that these events are often inadequately reported in publicly available reports. Because of the lack of these data and uncertainty about methods for synthesising them, individuals conducting systematic review
A systematic review is a scholarly synthesis of the evidence on a clearly presented topic using critical methods to identify, define and assess research on the topic. A systematic review extracts and interprets data from published studies on ...
s and meta-analyses of therapeutic interventions often unknowingly overemphasise health benefit. To balance the overemphasis on benefit, scholars have called for more complete reporting of harm from clinical trials.
Related terms
Serious adverse reactions are serious adverse events judged to be related to drug therapy. A SUSAR (suspected unexpected serious adverse reaction) should be reported to a drug regulatory authority under an investigational license by using the CIOMS form (or in some countries an equivalent form). "Unexpected" means that for an authorised (approved) medicinal product that the event is not described in the product's labeling, or in the case of an investigational (yet to be approved or disapproved) product that the event is not listed in the Investigator’s Brochure. That is, the AE is unexpected for the drug or device.
An adverse effect
An adverse effect is an undesired harmful effect resulting from a medication or other intervention, such as surgery. An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. The term compli ...
is an adverse event which is believed to be caused by a health intervention.
Footnotes
See also
* Adverse event
In pharmaceuticals, an adverse event (AE) is any unexpected or harmful medical occurrence that happens to a patient during medical treatment or a clinical trial. Unlike direct side effects, an adverse event does not necessarily mean the medicati ...
, including mild/minor
* Clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
* Good clinical practice
In drug development and production, good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for ...
(GCP)
* Data Monitoring Committees
* Pharmacovigilance
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products.
The etymological roots ...
* EudraVigilance (European Union
The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The u ...
)
* Directive 2001/20/EC (European Union
The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The u ...
)
* TGN1412, a drug that had SAEs in a clinical trial
* BIA 10-2474, a drug that had SAEs, including a fatality, in a clinical trial
External links
What Is A Serious Adverse Event?
(MedWatch)
ClinicalTrials.gov
from US National Library of Medicine
The United States National Library of Medicine (NLM), operated by the United States federal government, is the world's largest medical library.
Located in Bethesda, Maryland, the NLM is an institute within the National Institutes of Health. I ...
ICH Website
{{DEFAULTSORT:Serious Adverse Event
Clinical research
Clinical trials
Drug safety