Defined terms in the registry — page 3
195 documents of type defined term.
Documents
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The magnitude of a difference, expressed on the scale of the outcome or standardised. A significant result with an effect size below the minimal clinically important…
30 Jul 2026 -
The smallest change in an outcome that a patient would identify as meaningful. Frequently contested and frequently unavailable, and the Institute names the source of any…
30 Jul 2026 -
The inflation of false-positive rates that follows from testing many hypotheses. Controlled by a pre-specified testing hierarchy, whose position each reported endpoint…
30 Jul 2026 -
A pre-specified order in which endpoints are tested, in which testing stops at the first failure. An endpoint below the point of failure is not confirmatory regardless…
30 Jul 2026 -
Observations not collected. The assumption under which they are handled is rarely testable and is the most common unstated assumption in a trial report.
30 Jul 2026 -
A method for handling missing data by generating several completed datasets under a stated model and combining the results. Depends entirely on the plausibility of the…
30 Jul 2026 -
The outcome on which a trial is powered and against which its success is judged. A trial has one primary endpoint, or a small number designated co-primary with an…
30 Jul 2026 -
An outcome measured alongside the primary endpoint. Confirmatory only where it occupies a place in a pre-specified testing hierarchy that was reached.
30 Jul 2026 -
An outcome analysed without multiplicity control and without pre-specified inferential status. Hypothesis-generating in every case, including where the result is…
30 Jul 2026 -
A measurement substituted for a clinical outcome on the assumption that a change in one predicts a change in the other. Validation of that assumption requires…
30 Jul 2026 -
An outcome a person would notice or care about directly: death, an event, a symptom, a function. Distinguished throughout the document set from a surrogate.
30 Jul 2026 -
An endpoint counting the first occurrence of any of several component events. Interpretable only when the components are of comparable importance and move in the same…
30 Jul 2026 -
Major adverse cardiovascular events. Conventionally a three-point composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke; four- and…
30 Jul 2026 -
An outcome reported directly by the participant without interpretation by a clinician. At elevated risk of bias where the intervention produces a perceptible effect that…
30 Jul 2026 -
An analysis reporting the proportion of participants reaching a defined threshold. Reported by the Institute alongside the mean because a mean conceals the distribution…
30 Jul 2026 -
The outcome the Institute designates as primary for an indication across its whole document set, so that estimates for different compounds in that indication are…
30 Jul 2026 -
An effect expressed as the difference between the change in the active arm and the change in the placebo arm. The only form in which the Institute reports a within-arm…
30 Jul 2026 -
Any untoward occurrence in a participant, whether or not attributed to treatment. Ascertained by spontaneous report in most trials, which underestimates incidence…
30 Jul 2026 -
An adverse event that results in death, is life-threatening, requires hospitalisation, produces persistent disability or is a congenital anomaly. A regulatory…
30 Jul 2026 -
Cessation of randomised treatment because of an adverse event. Reported by the Institute in the summary-of-findings table alongside efficacy outcomes rather than in a…
30 Jul 2026 -
The reciprocal of the absolute risk increase for a harm. Reported alongside the number needed to treat wherever both are estimable.
30 Jul 2026 -
A ligand that binds a receptor and produces a response. Full agonists produce the maximal response the system can give; partial agonists produce less at full occupancy.
30 Jul 2026 -
A ligand producing a submaximal response at full receptor occupancy. May behave as an antagonist in the presence of a full agonist.
30 Jul 2026 -
A ligand that binds a receptor without producing a response and prevents an agonist from doing so.
30 Jul 2026 -
Preferential activation of one signalling pathway over another from the same receptor. Proposed as a means of separating a desired effect from receptor internalisation…
30 Jul 2026 -
The time for a plasma concentration to fall by half during the terminal elimination phase. Determines dosing interval, time to steady state and the time required for…
30 Jul 2026 -
The condition in which the amount of a compound entering the body equals the amount leaving it. Reached after approximately four to five half-lives of repeated dosing.
30 Jul 2026 -
The fraction of an administered dose reaching the systemic circulation unchanged. Low and variable for orally administered peptides, which is the constraint every oral…
30 Jul 2026 -
An excipient that increases absorption across a mucosal surface. In the oral peptide presentation in this document set it transiently raises local pH and increases…
30 Jul 2026 -
The apparent volume into which a compound distributes, computed from dose and plasma concentration. A small value indicates confinement to the circulation, as expected…
30 Jul 2026 -
The fraction of a compound bound to circulating protein and therefore not immediately available to distribute or be eliminated. Reversible albumin binding is the…
30 Jul 2026 -
The volume of plasma cleared of a compound per unit time. Together with volume of distribution it determines half-life.
30 Jul 2026 -
The time from administration to the maximum observed plasma concentration. For a subcutaneously administered acylated peptide this is measured in days rather than hours.
30 Jul 2026 -
The relationship between dose and the magnitude of effect. A monotonic relationship supports causal attribution; a non-monotonic one is reported by the Institute as…
30 Jul 2026 -
Rapid attenuation of response with repeated administration. Documented for several growth-hormone secretagogues and material to any claim about sustained effect.
30 Jul 2026 -
Reduction in receptor responsiveness following sustained stimulation, often through receptor internalisation. The pharmacological reason that non-pulsatile…
30 Jul 2026 -
A gut-derived hormone that potentiates insulin secretion in response to nutrient intake. The two principal human incretins are glucagon-like peptide-1 and…
30 Jul 2026 -
A compound activating the glucagon-like peptide-1 receptor, a class B G protein-coupled receptor signalling principally through Gαs. Effects include glucose-dependent…
30 Jul 2026 -
Glucose-dependent insulinotropic polypeptide, the second human incretin. Its contribution to the effects of dual agonists is substantially supported and not fully…
30 Jul 2026 -
A single molecule engineered to activate two receptors. In this document set the combinations of interest are GIP with GLP-1, and glucagon with GLP-1, which produce…
30 Jul 2026
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