Real-World EvidenceRWE, Routine-Practice Evidence
Clinical evidence about a medical product's use, benefits, or risks derived from analysing real-world data, unlike evidence from a controlled trial.
Clinical Trials & Real-World Evidence
Terms for clinical trial design and for evidence drawn from routine practice outside trials.
- Topic: Clinical Trials & Real-World Evidence
- 40 terms
- Editor reviewed
RegistryData Register, Clinical Register
An organised system collecting standardised information over time about individuals with a particular condition, procedure, or exposure, across multiple sites.
Secondary EndpointSecondary Outcome, Supportive Endpoint
An outcome measure assessed within a trial that provides supportive evidence about a treatment's effects, alongside the trial's primary endpoint.
Selection BiasSelection Effect, Sampling Bias
Bias arising when the individuals included in a study differ systematically from the broader population of interest, in ways linked to exposure and outcome.
Single-Arm TrialSingle-Arm Study, Uncontrolled Trial
A trial design in which all participants receive the same treatment without a concurrently randomised comparator, assessed against historical or external data.
Superiority TrialSuperiority Study, Superiority Design
A trial designed to show a new treatment produces a better outcome than its comparator, unlike a non-inferiority or equivalence trial.
Surrogate EndpointSurrogate Outcome, Surrogate Marker
A trial outcome used as a substitute for a direct clinical benefit measure, such as survival, based on its expected predictive relationship to that outcome.
Target Trial EmulationEmulated Trial, Target Trial Framework
A framework designing an observational study to closely emulate a hypothetical randomised trial answering the same causal question, specified before analysis.