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

Which trial type is specifically focused on treatment's impact on disease outcomes?

1. Exploratory Trial

2. Therapeutic Trial

3. Pharmacokinetic Trial

4. Confirmatory Trial

The correct answer is: Therapeutic Trial

The focus of a therapeutic trial is to evaluate the efficacy and safety of a treatment or intervention in improving disease outcomes. This type of trial is designed to determine whether a new treatment can significantly affect the course of a disease, compare it to existing therapies, or assess its potential benefits against a placebo. The primary goal is to establish reliable evidence of the treatment's effectiveness, which is essential for regulatory approval and clinical practice. In contrast, an exploratory trial is typically used in the early stages of development to investigate new treatment hypotheses and often assesses preliminary effects rather than definitive outcomes. Pharmacokinetic trials focus on how a drug is absorbed, distributed, metabolized, and excreted in the body, rather than directly measuring its impact on disease. Confirmatory trials, while also important, are usually conducted after a therapeutic trial has suggested effectiveness and aim to confirm results in a larger population. Thus, the therapeutic trial is distinctly aimed at understanding the direct effects of a treatment on patient outcomes in disease management.