Advanced Dental Admission Test (ADAT)

In clinical trials, what is emphasized in Phase 1 studies?

1. Large group of participants

2. Assessment of long-term outcomes

3. Testing safe dose range and toxicity

4. Understanding patient compliance

The correct answer is: Testing safe dose range and toxicity

In Phase 1 clinical trials, the primary focus is on the assessment of safety, specifically determining the safe dose range and identifying any potential toxicity associated with a new drug or treatment. During this phase, the clinical trial typically involves a small group of healthy volunteers or patients to evaluate how the drug is metabolized and excreted, as well as to monitor for any adverse effects. The goal is to gather crucial safety data that will guide dosage decisions in subsequent trial phases. This emphasis on safety and dosage is critical, as it lays the foundation for further testing in Phase 2 and Phase 3 studies, where the drug's efficacy and effectiveness are evaluated in larger populations. Other aspects, such as understanding patient compliance or assessing long-term outcomes, are more relevant in later phases of clinical research once the initial safety profile has been established.