phase iii clinical trial
Definition
- Noun:
- A large-scale, rigorous clinical trial conducted to confirm the effectiveness and monitor the side effects of a new treatment or drug in a large patient population. This trial phase occurs after preliminary evidence of efficacy and safety has been established in earlier phases (I and II). Its successful completion is typically required for a treatment to receive formal regulatory approval (e.g., from the FDA) for general use.
Usage Examples
- Noun:
- The new antiviral medication is now entering a phase III clinical trial to confirm its benefits for a broader population.
- Successful results from the phase III clinical trial are the final step before the company can apply for market authorization.
Advanced Usage
- "to be in a phase III clinical trial": Describes the status of a treatment currently undergoing this testing stage.
- The vaccine candidate is currently in a phase III clinical trial across multiple countries.
- "to advance to phase III": Indicates a treatment has progressed from earlier testing phases to this confirmatory stage.
- After promising Phase II data, the therapy was approved to advance to phase III.
Variants and Related Words
- Phase III trial (n): A common abbreviated form of "phase III clinical trial."
- Pivotal trial (n): A term often used synonymously with a phase III trial, emphasizing its critical role in the approval decision.
- Confirmatory trial (n): Another synonym highlighting its purpose of confirming results from earlier studies.
Synonyms
- Pivotal study: A large, definitive study designed to provide conclusive evidence about a treatment's benefit and risk.
- Confirmatory clinical trial: A trial that seeks to verify the safety and efficacy findings from earlier exploratory phases.
Related Phrases
- Randomized controlled trial (RCT): The standard, high-quality design typically used for a phase III clinical trial, where participants are randomly assigned to receive either the new treatment or a standard treatment/placebo.
- Primary endpoint: The main outcome measure (e.g., survival rate, reduction in symptoms) that a phase III clinical trial is specifically designed to evaluate.
Noun
-
a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA
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