Phase IV trials, which typically enroll thousands of people, are conducted after a treatment has been approved by the Food and Drug Administration and is available for doctors to prescribe to patients not enrolled in a clinical trial. These trials study how well a treatment works in addition to side effects and safety over a long period of time. Another purpose of phase IV trials is to obtain real-world evidence. Real-world evidence is information obtained from clinical trials as well as other sources such as electronic health records and patient registries.
- ASCO: Phases of Clinical Trials
- Emory University (Video): Dr. Bassel El-Rayes Explains the Purpose of a Phase 4 Trial
- Pfizer Global Breast Cancer Advocacy Webinar Series (Video): Session 2: Real-World Evidence
- Food and Drug Administration: Real-World Evidence
Phase IV Clinical Trials
- ClinicalTrials.gov: Phase IV Breast Cancer Trials
Last Modified on April 29, 2022