The science and activities relating to detecting, assessing, understanding, and preventing adverse effects of a medicine throughout its entire lifecycle.
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
An improvement in a patient's condition resulting from belief in receiving an effective treatment, occurring independently of any direct pharmacological action.
A trial designed to evaluate a treatment under conditions resembling routine clinical practice, using broad eligibility and outcomes relevant to real-world decisions.
The main outcome measure a trial is specifically designed and statistically powered to assess, the principal basis for judging its success.
The estimated probability that an individual would receive a particular treatment given their observed characteristics, used to balance confounders in observational studies.
A trial design in which participants are randomly assigned to an experimental intervention or a comparator, the gold standard for causal evidence.
The process of assigning trial participants to treatment groups by chance, producing groups comparable on both known and unknown influencing factors.
Routinely collected information about patient health or healthcare delivery that may support research and decision making when fit for a defined purpose.