How are clinical trials staged?
Phase 1
20-80 participants
This is the first time an investigational drug will be tested in people and will usually involve a small group of healthy volunteers (around 20-80 people). Safety tests will be the primary aim of this phase.
How are clinical trials staged?
Phase 2
100-300 participants
Having been tested in Phase 1 on healthy volunteers, Phase 2 will test how safe and potentially effective an investigational drug is for people with the relevant condition and begin to establish dosing levels. To ensure the results are assessed objectively, it will generally be tested against a placebo. It usually involves 100-300 participants who have the condition.
How are clinical trials staged?
Phase 3
1000-3000 participants
If Phase 2 shows that the investigational drug has encouraging results in a small group of people it moves to Phase 3. Phase 3 expands the patient numbers. These clinical trials usually involve 1000-3000 participants and are essential for testing the safety and effectiveness of an investigational drug. It may also investigate how it compares to any existing standard of care, suitable dosing levels and any side effect issues.
How are clinical trials staged?
Phase 4
These involve use of the drug in the ‘real world’, rather than the closely controlled conditions of Phase 1-3 clinical trials, after the drug has been approved, to evaluate its long-term effects.
Why take part in a clinical trial?
All eligible clinical trial participants will receive:
Study drug (investigational drug or placebo)
All eligible clinical trial participants may receive:
Trial-related care i.e. more health-related monitoring and assessments while in the study and consultation with a study doctor
All eligible clinical trial participants will receive:
Trial-related visits and health assessments
Taking part is completely voluntary and you can decide to leave at any time.
You may experience unwanted side effects. These are listed in full in the informed consent form, although we can never predict them all.
By taking part you could be helping provide future MS patients with potential new treatment options
