Chemotherapy Biotherapy Certification ONS Practice Testq

What is the primary focus of Phase 1 in a clinical trial?

1. Defines new uses and dosing schedules

2. Determines drug activity and tolerable dose

3. Tests the efficacy across multiple cancers

4. Evaluates patient quality of life

The correct answer is: Determines drug activity and tolerable dose

Phase 1 of a clinical trial is primarily focused on determining drug activity and the tolerable dose. This phase is critical as it typically involves a small number of participants and aims to assess the safety of a new drug or treatment. The main objectives include understanding the pharmacokinetics (how the drug is absorbed, distributed, metabolized, and excreted) and pharmacodynamics (the effects of the drug on the body), which are both essential for establishing the appropriate dosage levels that can be safely administered to humans. During Phase 1, researchers closely monitor for any adverse reactions and collect information on the medication's effects on the body, allowing them to identify a safe and effective dose range. This initial phase sets the foundation for further testing in later phases, where the focus will shift more towards efficacy and broader patient populations. While aspects like defining new uses, testing across multiple cancers, or evaluating patient quality of life may be investigated in later phases, they are not the primary objectives of Phase 1 trials.