Chemotherapy Biotherapy Certification ONS Practice Testq

How many phases are there in a standard clinical trial?

1. 2

2. 3

3. 4

4. 5

The correct answer is: 4

In a standard clinical trial, there are four distinct phases, each serving a unique purpose in the investigation of new treatments or drugs. Phase I focuses on assessing the safety, tolerability, and pharmacokinetics of a treatment in a small group of participants, usually healthy volunteers. This phase helps determine the appropriate dosage and identify any potential side effects. Phase II expands the scope, involving a larger group of participants, often those who have the condition that the treatment aims to address. The primary goal here is to evaluate the treatment's efficacy as well as further assess its safety. Phase III is a critical phase where the treatment is compared to the standard of care in a larger population. This phase seeks to gather more comprehensive data on effectiveness, monitor side effects, and identify any variations in response among different demographics. Finally, Phase IV occurs after the treatment has received regulatory approval and is available to the public. This phase involves post-marketing surveillance to monitor the long-term effects and ongoing safety of the treatment. Understanding the four phases of clinical trials is crucial for healthcare professionals as it aids in comprehending how new treatments are rigorously tested and validated before they are widely adopted in clinical practice.