Phase III clinical trials represent the critical final stage of testing before a new treatment can be submitted to the FDA for approval. They involve thousands of participants and are conducted at multiple sites around the country and world.
What Happens in Phase III?
Phase III trials are designed to:
- Confirm effectiveness, Demonstrate that the treatment works in a large, diverse population
- Monitor safety, Identify side effects that may only appear in large populations or with longer exposure
- Compare to existing treatments, Measure how the new treatment performs against the current standard of care
- Collect labeling data, Gather information needed for prescribing guidelines and drug labeling
Who Participates in Phase III?
Phase III trials typically enroll 1,000 to 3,000 participants, sometimes more. Participants have the condition being studied and meet specific eligibility criteria. Studies are conducted at multiple research sites simultaneously.
How Long Does Phase III Last?
Phase III trials typically last 1 to 4 years, depending on the condition being studied and the endpoints being measured.
What Happens After Phase III?
If Phase III results demonstrate that a treatment is both effective and safe, the drug sponsor submits a New Drug Application (NDA) or Biologics License Application (BLA) to the FDA. FDA review typically takes 6 to 12 months.
Why Your Participation Matters
Without Phase III participants, no new drug can be approved. The study volunteers of today create the treatments that patients will access tomorrow.
NuLine participates in Phase II and Phase III trials across multiple therapeutic areas. Browse our current studies.