Term

 Description

Adverse event (AE) (largely considered synonymous with  adverse experience)

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. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.[1]

Adverse event of special interest (AESI)

A noteworthy event for the particular product or class of products that a sponsor may wish to monitor carefully. It could be serious or non-serious (e.g. hair loss, loss of taste, impotence), and could include events that might be potential precursors or prodromes for more serious medical conditions in susceptible individuals. Such events should be described in protocols or protocol amendments, and instructions provided for investigators as to how and when they should be reported to the sponsor.

Adverse drug reaction (ADR) (largely considered synonymous with adverse drug effect, though see Aronson 2013 for reflections on this

In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase "responses to a medicinal product" means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. Regarding marketed medicinal products, a well-accepted definition of an adverse drug reaction in the post-marketing setting is found in WHO Technical Report 498 [1972] and reads as follows: A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function. The old term "side effect" has been used in various ways in the past, usually to describe negative (unfavourable) effects, but also positive (favourable) effects. It is recommended that this term no longer be used and particularly should not be regarded as synonymous with adverse event or adverse reaction.

Benefit-risk analysis

Examination of the favourable (beneficial) and unfavourable results of undertaking a specific course of action. (While this phrase is still commonly used, the more logical pairings of benefit-harm and effectiveness-risk are slowly replacing it).(2)

Case control studies

Studies that compare cases with a disease to controls without the disease, looking for differences in antecedent exposures.[8]

Case reports

Reports of the experience of single patients. As used in pharmacoepidemiology, a case report describes a single patient who was exposed to a drug and experiences a particular outcome, usually an adverse event.[8]

Case series

Reports of collections of patients, all of whom have a common exposure, examining what their clinical outcomes were. Alternatively, case series can be reports of patients who have a common disease, examining what their antecedent exposures were. No control group is present. (3)

Causality assessment

Method for assigning probability of causation to a suspected adverse drug reaction.[1]

Clinical development programme

This refers to all clinical trials being conducted with the same investigational drug, regardless of indication or formulation. (4)

Clinical trial/study

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamics effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.[10]