All About Phase IV Clinical Trials

In the last 3 months, we highlighted what to know about phase I, phase II, and phase III clinical trials. In the last of our four-part series, we are discussing phase IV clinical trials.

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

 

• Category: Inside Clinical Trials
• Tag: Clinical Trial Diversity, Clinical Trial Navigation, Clinical Trial Terms, Inside Clinical Trials