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Serious adverse event

Negative medical occurrence during a human drug trial

Negative medical occurrence during a human drug trial

In drug development, serious adverse event (SAE) is defined as any untoward medical occurrence during a human drug trial that at any dose

  1. Results in death
  2. Is life-threatening
  3. Requires inpatient hospitalization or causes prolongation of existing hospitalization
  4. Results in persistent or significant disability/incapacity
  5. May have caused a congenital anomaly/birth defect
  6. 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 events 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.”

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 reviews 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.

Footnotes

References

  1. (9 September 2020). "What is a Serious Adverse Event?". FDA.
  2. Expert Working Group (Efficacy) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).. (August 25, 2007). "Guideline for Industry - Clinical safety data management: definitions and standards for expedited reporting.". FDA Center for Drug Evaluation and Research.
  3. Expert working group (efficacy) of the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use. (August 25, 2007). "Guideline for Industry Structure and Content of Clinical Study Reports.". FDA Center for Drug Evaluation and Research.
  4. (2001). "Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas.". JAMA.
  5. (2005). "Challenges in systematic reviews that assess treatment harms.". Ann Intern Med.
  6. (2004). "Better reporting of harms in randomized trials: an extension of the CONSORT statement.". Ann Intern Med.
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