Adverse event
Encyclopedia
An adverse event is any adverse change in health or side effect that occurs in a person who participates in a clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...

 while the patient is receiving the treatment (study medication, application of the study device, etc.) or within a previously specified period of time after the treatment has been completed.

AEs in patients participating in clinical trials must be reported to the local institutional review board
Institutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...

 (IRB) and the study sponsor. Adverse events categorized as "serious" (for example death, illness requiring hospitalization, events deemed life-threatening, or involving cancer or fetal exposure) must be reported to the regulatory authorities immediately, whereas minor adverse events are merely documented in the annual summary sent to the regulatory authority.

The sponsor collects AE reports from the local researchers, and notifies all participating sites of the AEs at the other sites, as well as both the local investigators' and the sponsors' judgment of the seriousness of the AEs. This process allows the sponsor and all the local investigators access to a set of data that might suggest potential problems with the study treatment while the study is still ongoing.

Types of adverse events

All clinical trials have the potential to produce AEs. AEs are classified as serious or minor; expected or unexpected; and study-related, possibly study-related, or not study-related.

For example, while a study that tests the effectiveness of a new blood pressure cuff for a period of 10 minutes might seem innocuous, the potential exists for the patient's skin to be irritated by the device. Patients in that study might also die during that 10 minute period. Both skin irritation and sudden death would be considered AEs. In this case, the skin irritation would be classified as not serious, unexpected, and possibly study-related. The death would be classified as serious and unexpected (unless the patient was already at death's door). The local researcher would use his/her medical judgment to determine whether the death could have been related to the study device.

Both the skin irritation and the death are unexpected events, and should alert the researcher to the potential existence of a problem with the device (for instance, it could have malfunctioned and shocked the patient). The researcher would report these AEs to the local IRB and to the sponsor, and await direction on whether to stop the study. If the researcher feels there is an imminent danger posed by the device, he or she can use medical discretion to stop patients from participating in the study.

An adverse event can also be declared in the normal treatment of a patient which is suspected of being caused by the medication being taken or a medical device used in the treatment of the patient.

In Australia, 'Adverse EVENT' refers generically to medical errors of all kinds, surgical, medical or nursing related. The most recent available official study (1995) indicated 18,000 deaths per year are a result of hospital care. The Medical Error Action Group is lobbying for legislation to improve the reporting of AEs and through quality control, minimize the needless deaths.

Reporting of adverse events

Researchers participating in a clinical trial must report all adverse events to the drug regulatory authority of the respective country where the drug or device is to be registered [e.g. Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

 (FDA) if it is US]. Serious AEs must be reported immediately; minor AEs are 'bundled' by the sponsor and submitted later.

Database of adverse events

The FDA provides a database for reporting of adverse events called the Manufacturer and User Facility Device Experience Database (MAUDE)[1]. The data consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996, and is open for public view.

See also

  • Clinical trial
    Clinical trial
    Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...

  • Good clinical practice
    Good clinical practice
    Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...

     (GCP)
  • Data Monitoring Committees
    Data Monitoring Committees
    A Data Monitoring Committee — sometimes called a Data and Safety Monitoring Board — is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.- Need for a DMC :...

  • Serious adverse event
    Serious adverse event
    A serious adverse event 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...

  • Adverse effect
    Adverse effect
    In medicine, an adverse effect is a harmful and undesired 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. If it results from an unsuitable or incorrect dosage or...

  • Adverse drug reaction
    Adverse drug reaction
    An adverse drug reaction is an expression that describes harm associated with the use of given medications at a normal dosage. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs...

  • Pharmacovigilance
    Pharmacovigilance
    Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...

  • EudraVigilance
    EudraVigilance
    EudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area .The European...

     (European Union
    European Union
    The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...

    )
  • Directive 2001/20/EC
    Directive 2001/20/EC
    The Clinical Trials Directive is a European Union directive that aimed at...

     (European Union
    European Union
    The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...

    )

External links

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