Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

If an investigational product has already demonstrated clinical benefits, what type of trial does this represent?

1. Exploratory Trial

2. Phase 1 Trial

3. Confirmatory Trial

4. Pilot Trial

The correct answer is: Confirmatory Trial

A trial that follows the demonstration of clinical benefits from an investigational product typically represents a Confirmatory Trial. This type of trial is designed to provide conclusive evidence regarding the efficacy and safety of the product, as it aims to confirm the findings from earlier studies, often in a larger sample size and over a longer duration. Confirmatory trials are critical in the drug development process as they gather the necessary data to support regulatory approval and wider clinical use. The focus here is on verifying the therapeutic effects and ensuring that the product performs consistently across diverse populations and settings. In contrast, exploratory trials primarily seek to generate hypotheses or gather preliminary data about a product, Phase 1 trials focus on safety and dosing mainly in healthy volunteers, and pilot trials are smaller studies that assess feasibility rather than conclusive evidence of efficacy. Each of these trial types serves different purposes within the broader clinical research framework, but a product that has already demonstrated clinical benefits will progress to confirmatory trials to validate those findings and facilitate subsequent approval processes.