“A Phase 3 trial is randomized, double-blind, and placebo-controlled” – What it signifies?
We sometime confuse the terminologies of clinical trial and whenever you come across certain clinical trial – you will look into the clinical trial design. Here as it mentioned particular trial is randomized, double-blind, and placebo-controlled. If you break down and analyse each component, then clinical trial design methodology will be understanding.
- Randomized: Each study subject is randomly assigned to receive either the study treatment or a placebo.
- Blind: The subjects involved in the study do not know which study treatment they receive. If the study is double-blind, the researchers also do not know which treatment a subject receives. This intent is to prevent researchers from treating the two groups differently. A form of double-blind study called a “double-dummy” design allows additional insurance against bias. In this kind of study, all patients are given both placebo and active doses in alternating periods.
- Placebo-controlled: The use of a placebo allows the researchers to isolate the effect of the study treatment from the placebo effect.
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