Study design
Phase 1 trial
An early human trial mainly assessing safety, dosing and tolerability.
What it means
Definition
Phase 1 trial. Phase 1 trials are not designed primarily to prove effectiveness. They usually involve small numbers of participants and focus on safety signals and dose selection.
What it can tell you
It can show how close the evidence is to a real human health outcome.
What it cannot tell you
It cannot prove that a treatment works in people unless human outcome data are available.
Headline trap
Why this matters in headlines
A phase 1 cancer study may be promising but should not be framed as established treatment benefit.