Clinical trial phase I involves which of the following?

Clinical trial phase I involves which of the following?

• A. Involves 1000 to 5000 volunteers and is designed to evaluate effectiveness
• B. Involves 20 to 100 patient volunteers and the intended to determine safety and dosage
• C. Involves 5000 to 10000 volunteers and monitors adverse effects
• D. Involves 10 to 50 volunteers and measures long-term outcomes

Answer: (B)

Phase I trials focus on safety and determining the appropriate dose in a small group. They enroll about 20 to 100 volunteers to see how the drug behaves in the body, establish safe dose ranges, and assess initial tolerability. This early-stage testing isn’t about proving effectiveness but about establishing safety and dosage guidelines before larger studies. The option that describes 20 to 100 volunteer patients and aims to determine safety and dosage fits this purpose best. Larger trials involving thousands of people are designed to evaluate effectiveness and gather more safety data (Phase II/III), while very small studies or those focusing on long-term outcomes don’t align with Phase I goals.

Phase I trials focus on safety and determining the appropriate dose in a small group. They enroll about 20 to 100 volunteers to see how the drug behaves in the body, establish safe dose ranges, and assess initial tolerability. This early-stage testing isn’t about proving effectiveness but about establishing safety and dosage guidelines before larger studies. The option that describes 20 to 100 volunteer patients and aims to determine safety and dosage fits this purpose best. Larger trials involving thousands of people are designed to evaluate effectiveness and gather more safety data (Phase II/III), while very small studies or those focusing on long-term outcomes don’t align with Phase I goals.