Serious adverse event
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2008-05-27T16:29:59Z
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A '''serious [[adverse event]]''' (SAE) in human [[drug]] trials are defined as any untoward
medical occurrence that at any dose results in
#death,
#is [[life-threatening]]
#requires inpatient [[hospitalization]] or prolongation of existing hospitalization
#results in persistent or significant disability/incapacity, or
#is a congenital anomaly/birth defect.<ref name=Defs>{{cite web | author=Expert Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). | title=Guideline for Industry - Clinical safety data management: definitions and standards for expedited reporting. | url=http://www.fda.gov/cder/guidance/iche2a.pdf | format=PDF | date=August 25, 2007 | publisher=FDA Center for Drug Evaluation and Research}}}</ref>
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.<ref name=Defs/> Adverse events are further defined 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.”<ref name=Defs/>
==Research==
Investigators in human clinical trials are obligated to report these events in clinical study reports <ref>{{cite web | author=Expert working group (efficacy) of the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use. | title=Guideline for Industry
Structure and Content of Clinical Study Reports. | url=http://www.fda.gov/cder/guidance/iche3.pdf | format=PDF | date=August 25, 2007 | publisher=FDA Center for Drug Evaluation and Research}}}</ref> . Research suggests that these events are often inadequately reported in publicly available reports.<ref>{{cite journal | author=Ioannidis JP, Lau J.| title=Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. | journal=JAMA | year=2001 | volume=285(4) | pages=437–43 | pmid=11242428| doi=10.1001/jama.285.4.437 }}</ref> Because of the lack of these data and uncertainty about methods for synthesising them, individuals conducting [[systematic review]]s and meta-analysis of therapeutic interventions often unknowingly overemphasise health benefit.<ref>{{cite journal | author=Chou R, Helfand M.| title=Challenges in systematic reviews that assess treatment harms. | journal=Ann Intern Med | year=2005 | volume=142(12 Pt 2) | pages=1090–0 | pmid=15968034 }}</ref> In order to balance the overemphasis on benefit, scholars have called for more complete reporting of harm from clinical trials.<ref>{{cite journal | author=Ioannidis JP, Evans SJ, Gøtzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D; CONSORT Group. | title=Better reporting of harms in randomized trials: an extension of the CONSORT statement. | journal=Ann Intern Med | year=2004 | volume=141(10) | pages=781–8 | pmid=15545678 }}</ref>
==Related Terms==
Serious [[adverse effects]] , serious adverse reactions, or suspected unexpected serious adverse reactions (SUSAR) are serious adverse events judged to be related to therapy. A SUSAR is to be reported to the regulatory authority by using the [[Council for International Organizations of Medical Sciences|CIOMS]] form:
* The event must be a SAE.
* There must be a certain degree of probability that the event is an adverse reaction on the administered drug.
* The adverse reaction must be unexpected, that is to say, not foreseen in the SPC text (Summary of Product Characteristics (for an authorised medicinal product)) or the [[Investigator's Brochure|Investigator’s Brochure]] (for an unauthorised medicinal product).
==Footnotes==
<div class="references-small"><references/></div>
==See also==
* [[Clinical trial]]
* [[Good clinical practice]] (GCP)
* [[Data Monitoring Committees]]
* [[Pharmacovigilance]]
* [[EudraVigilance]] ([[European Union]])
* [[Directive 2001/20/EC]] ([[European Union]])
* [[TGN1412]]
== External links ==
*[http://www.fda.gov/medwatch/report/DESK/advevnt.htm What Is A Serious Adverse Event?] (MedWatch)
*[http://www.fda.gov/ FDA Website]
*[http://www.clinicaltrials.gov/ ClinicalTrials.gov] from US [[National Library of Medicine]]
*[http://www.ich.org ICH Website]
*[http://www.pharmaschool.co.uk/ PharmaSchool JargonBuster Clinical Trial Terminology Dictionary]
[[Category:clinical research]]
[[Category:Pharmaceutical industry]]
[[de:Schwerwiegendes unerwünschtes Ereignis (Klinische Studie)]]
[[fr:Événement indésirable grave]]