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

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According to ICH E8, what type of study is characterized by being randomized, controlled, and aimed at establishing efficacy?

Phase 1 studies
Therapeutic confirmatory studies
Exploratory studies
Bioequivalence studies

The correct answer is: Therapeutic confirmatory studies

The type of study characterized by being randomized, controlled, and aimed at establishing efficacy is therapeutic confirmatory studies. These studies are specifically designed to provide evidence for the effectiveness of a treatment by comparing it to a control under carefully controlled conditions. The randomization helps to eliminate bias in treatment assignment, ensuring that the results are reliable and applicable to the broader population. Therapeutic confirmatory studies are typically conducted after exploratory studies have suggested a potential benefit, and they are critical in the drug development process for regulatory approval. They focus on confirming the efficacy of the intervention, which is essential for establishing the therapeutic benefits and justifying the treatment's risk-benefit profile. In contrast, phase 1 studies primarily focus on safety and pharmacokinetics rather than efficacy, exploratory studies are designed to generate hypotheses rather than definitively test treatment effectiveness, and bioequivalence studies are aimed at comparing the bioavailability of two formulations of a drug rather than establishing efficacy.