Clinical trials are there to make sure that a new treatment:
- is safe and effective
- really does work better than a placebo (dummy) treatment
- doesn’t have any dangerous side-effects.
Clinical trials have different phases: initially, the drug is tested in small numbers of people to make sure that it’s safe, before it’s tested in hundreds and sometimes thousands of patients.
This testing in large numbers is absolutely vital: reports of a good result in one or two patients do not necessarily mean that a therapy will be safe and effective for everyone.
All treatments have to go through three phases of clinical trials before they’re approved.
After this process – which can take up to 10 years and cost millions of pounds – health regulators and doctors can be confident that a treatment is safe and will help the people who need it.
The clinical trial stage comes after a treatment is shown to protect or restore hearing in experimental models in the laboratory.
What are the phases of a clinical trial?
Phase 1 makes sure that the medicine is safe for people to use.
Phase 2 tests if the medicine is effective:
- Does it prevent or treat the condition?
- What’s the dosage that people need to take?
Phase 3 is usually a trial that involves a larger number of people. It’s there to:
- confirm the medicine is safe and effective
- identify any side effects
- compare the medicine’s benefits in relation to its risks.
Once a medicine is approved and available on the market, there’s still one last phase.
Phase 4 clinical trial:
- looks for any side effects that were not detected in the earlier phases
- can also assess how well the treatment works.
How to take part in a clinical trial
There are different clinical trials underway that aim to test treatments that protect and/or regenerate hearing, and silence tinnitus.
For up-to-date information on clinical trials in the UK – and why they are so important – please visit the National Institute for Health’s Be Part of Research website.
If you're interested in taking part in an international clinical trial taking place outside the UK, please use the World Health Organisation's International Clinical Trials Registry Platform on the NHS Choices website.