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

What is the typical focus of Phase I trials?

1. Efficacy in patients

2. Dosing and safety in healthy subjects

3. Long-term outcomes post-approval

4. Comparative effectiveness

The correct answer is: Dosing and safety in healthy subjects

Phase I trials primarily focus on assessing the safety and dosing of a new drug or intervention. In these trials, the primary objective is to determine how the drug affects healthy subjects, including how it is metabolized and its pharmacokinetic properties. Researchers aim to identify any potential side effects and to establish a safe dosage range before proceeding to later phases. During Phase I, careful monitoring is conducted to gather data on how the drug interacts with the body, which forms the foundational knowledge necessary for further testing of efficacy and effectiveness in larger and more varied patient populations in subsequent phases. This focus on safety and dosing parameters ensures that when the substance progresses to Phase II and III trials, it is done with a clear understanding of the appropriate dosage and safety profile. This foundational knowledge is crucial, as it helps to mitigate risks associated with drug development and enhances the probability of success in future testing phases.