Confirmatory trial
Confirmatory Trial (pronunciation: /kənˈfɜːrmətɔːri traɪəl/) is a term used in Clinical Research to refer to a type of Clinical Trial that is designed to confirm the preliminary evidence accumulated from Exploratory Trials.
Etymology
The term "Confirmatory Trial" is derived from the English words "confirm" and "trial". "Confirm" comes from the Latin word "confirmare", which means to establish or strengthen. "Trial" comes from the Old French word "trial", which means a test or examination.
Definition
A Confirmatory Trial is a late-stage, usually phase III, clinical trial in the development of a new drug or treatment. The main purpose of these trials is to provide definitive evidence about the effectiveness and safety of a new intervention. These trials are usually randomized, controlled, and are conducted on a large patient population.
Related Terms
- Randomized Controlled Trial: A type of scientific experiment that aims to reduce bias when testing a new treatment. The people participating in the trial are randomly allocated to either the group receiving the treatment under investigation or to a group receiving standard treatment or placebo treatment as the control.
- Phase III Trials: These are large, confirmatory trials to determine the effectiveness and monitor the side effects of new interventions in large populations of patients with a specific disease.
- Clinical Research: A branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use.
- Exploratory Trials: These are early phase trials (usually phase I or II) that are designed to identify the best dose and schedule for new treatments and to understand their safety profile.
See Also
External links
- Medical encyclopedia article on Confirmatory trial
- Wikipedia's article - Confirmatory trial
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