What is the primary goal of phase 1 clinical trial studies?

What is the primary goal of phase 1 clinical trial studies?

• A. To evaluate the efficacy of a drug
• B. To assess the safety and tolerability of a drug
• C. To gather data on long-term effects
• D. To understand participant demographics

Answer: (B)

In phase 1 clinical trials, the primary focus is on assessing the safety and tolerability of a new drug or treatment. This stage involves a small group of healthy volunteers and aims to determine how the drug is processed in the body, its pharmacokinetics, and any potential side effects or adverse reactions that may occur. The objective is to establish a safe dosage range and to identify any safety issues before the drug is tested in larger groups during later phases of clinical development. While other phases of clinical trials are designed to evaluate efficacy, gather data on long-term effects, or understand participant demographics, phase 1 specifically prioritizes safety to ensure that any further testing can be conducted with acceptable risk to participants.

In phase 1 clinical trials, the primary focus is on assessing the safety and tolerability of a new drug or treatment. This stage involves a small group of healthy volunteers and aims to determine how the drug is processed in the body, its pharmacokinetics, and any potential side effects or adverse reactions that may occur. The objective is to establish a safe dosage range and to identify any safety issues before the drug is tested in larger groups during later phases of clinical development.

While other phases of clinical trials are designed to evaluate efficacy, gather data on long-term effects, or understand participant demographics, phase 1 specifically prioritizes safety to ensure that any further testing can be conducted with acceptable risk to participants.