Serious adverse event

Serious adverse event

A serious adverse event (SAE) in human drug trials are defined as any untowardmedical 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.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}]

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 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.”

Research

Investigators in human clinical trials are obligated to report these events in clinical study reports [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 IndustryStructure 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}] . Research suggests that these events are often inadequately reported in publicly available reports. [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 ] Because of the lack of these data and uncertainty about methods for synthesising them, individuals conducting systematic reviews and meta-analysis of therapeutic interventions often unknowingly overemphasise health benefit. [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 ] In order to balance the overemphasis on benefit, scholars have called for more complete reporting of harm from clinical trials. [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 ]

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 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 (for an unauthorised medicinal product).

Footnotes

ee 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]


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