About clinical trials

What are clinical trials?

  • Clinical trials allow us to learn more about the effects of an investigational drug in people, but only after it has gone through extensive testing in the laboratory.
  • Joining a clinical trial means your child can be part of helping medical advancement. This is vital in the development of potential new treatments.
  • All drugs must be tested in clinical trials (also known as clinical research studies) before they can be approved and made available for use.
  • Without people like you or your child willing to volunteer their time for medical research, it would not be possible to evaluate investigational drugs for medical conditions. Clinical trial volunteers are vital to making the difference in medical advances.
  • Every clinical study must be reviewed and approved by committees called Institutional Review Boards (IRBs) and Ethics Committees (ECs) to ensure the rights of participants are protected.

How are clinical trials staged?

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Phase 1 clinical trials

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.

This information is about clinical trials in general – it is not specific to CHARGE.

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Phase 2 clinical trials

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.

This information is about clinical trials in general – it is not specific to CHARGE.

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Phase 3 clinical trials

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 a larger group of 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.

This information is about clinical trials in general – it is not specific to CHARGE.

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Phase 4 clinical trials

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.

This information is about clinical trials in general – it is not specific to CHARGE.

Why take part in a clinical trial?

All eligible clinical trial participants will receive:

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Potential access to an investigational drug

Note: This information is about clinical trials in general – it is not specific to CHARGE.

All eligible clinical trial participants will receive:

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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:

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Trial-related visits and health assessments

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Taking part is completely voluntary and your child can decide to leave at any time and for any reason (or no reason at all)

Your child may experience unwanted side effects. These are listed in full in the informed consent form, although we can never predict them all

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By taking part your child could be helping provide future MS patients with potential new treatment options

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