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

What is the expected outcome of a Confirmatory Trial?

1. To generate preliminary safety data

2. To create hypotheses for further study

3. To provide strong clinical data evidence about safety and efficacy

4. To develop new treatment methodologies

The correct answer is: To provide strong clinical data evidence about safety and efficacy

The expected outcome of a Confirmatory Trial is to provide strong clinical data evidence about safety and efficacy. Confirmatory Trials are designed to test hypotheses that have been generated in earlier exploratory or Phase II trials. These trials focus on measuring the drug's effectiveness in a specific population and are structured to confirm the treatment's impact and safety profile with sufficient statistical power. In Confirmatory Trials, the endpoints are clearly defined, allowing for robust conclusions about how well a treatment works compared to a control or standard of care. This strong evidence is crucial for regulatory bodies when determining whether to approve a new medication for public use. The results may lead to definitive claims regarding the treatment's efficacy and safety, thereby influencing clinical practice and healthcare decisions. Other choices involve earlier phases of research or different objectives. For instance, generating preliminary safety data pertains to the initial assessment of safety rather than confirming established outcomes. Creating hypotheses for further study relates more to the design of earlier investigations rather than the confirmatory phase. Developing new treatment methodologies is not the primary focus of Confirmatory Trials, which typically assess established interventions rather than innovating new approaches.