Guide · Reading research

How new treatments are tested: the phases of a clinical trial

A new medicine passes through several stages of testing in people, each one larger and asking a different question.

Sep 25, 2026Antopeloni2 min read
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Before people

New treatments are first studied in the laboratory and, where required, in animals. Only promising and apparently safe ones move on to trials in people.

The phases

  1. Phase I

    A small group — often 20 to 80 people — to study safety, side effects and how the body handles the treatment.

  2. Phase II

    A larger group, often several hundred, to see whether it works and to keep studying safety.

  3. Phase III

    Large groups, often 1,000 to 3,000 people or more, to confirm it works, watch for side effects and compare it with standard treatment.

  4. Phase IV

    After approval, studies continue in the wider population to track long-term benefits and rare side effects.

Taking part

Trials are voluntary and follow ethics rules: participants are told the purpose, risks and possible benefits before giving informed consent, and can leave at any time.

Sources

Editorial update: 2026-09-26.

Medical disclaimer: this is a source-linked educational summary, not individual medical advice, diagnosis, prescription or interpretation of personal results. For severe or rapidly worsening symptoms, call 115.

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