Registry vocabulary
What “phase” means on a ClinicalTrials.gov record
These definitions are the standard FDA/ICH labels applied to the registry Phase field. They are not a result for a specific NCT number and not a ranking of treatments. Each hub lists recruiting studies from this snapshot.
Phase 1
First-in-human or early safety and dose studies. Small groups. Not designed to prove a treatment works.
Phase 2
Looks for a signal of benefit and continues to watch side effects, still in a limited population.
Phase 3
Larger comparative studies, often used in approval decisions. Not a guarantee of approval or benefit.
Phase 4
The product is already approved for some use. The study asks new real-world or additional-use questions.
Observational
Researchers measure what already happens. They do not assign the experimental treatment as the intervention.
Not a drug phase (N/A)
Devices, behavioral programs, diagnostics, and some procedures do not use the drug phase ladder.
Related: observational vs interventional · glossary · methodology