Chemotherapy Biotherapy Certification ONS Practice Testq

What does Phase 4 of a clinical trial focus on?

1. Long-term safety of the treatment

2. Establishing initial doses

3. Assessing acute drug effects

4. Determining patient eligibility

The correct answer is: Long-term safety of the treatment

Phase 4 of a clinical trial, often referred to as post-marketing surveillance, is primarily focused on the long-term safety and effectiveness of a treatment after it has been approved for public use. During this phase, the treatment is monitored in a larger, more diverse population over an extended period to identify any rare or long-term side effects that may not have been evident during the earlier phases of clinical trials. This phase is critical for understanding how the treatment performs in real-world settings, outside the controlled environment of clinical trials. Additionally, it can provide insights into the treatment's overall benefit-risk profile in the broader population, thus ensuring that ongoing safety monitoring continues after the treatment's release. Other phases of clinical trials typically focus on establishing initial doses, assessing acute drug effects, and determining patient eligibility, which are not the primary aim of Phase 4.