Clinical trials can be an important treatment option for people with ocular melanoma.
Here, we answer important questions, like:
- What are clinical trials?
- What is the clinical trial process?
- Who can take part in a clinical trial?
- How can I find a clinical trial?
What are clinical trials?
Clinical trials are medical research studies involving patients. They help researchers and doctors find new ways to prevent, diagnose, or treat diseases.
Clinical trials are especially important for OMs because they can help:
- Understand what causes OMs
- Find ways to diagnose OMs at an earlier stage
- Test and develop better treatments
- Improve how safe and effective new/current treatments are
- Improve care and side effect management
If you are interested in taking part in a clinical trial, ask your doctor or nurse if you are eligible for any trials.
It is sometimes difficult to find clinical trials that you can be a part of. We have created a clinical trial database to help you find possible clinical trials.
You can also subscribe to receive notifications on any changes to our Clinical Trials Database to help you stay updated.
What is the clinical trial process?
Treatments undergo thorough testing before they become available to patients.
For example, a treatment may first be studied in a laboratory to see how cells respond. They might then be tested on animals before they can be tested on humans.
Clinical trials must follow strict rules to ensure safety. An independent ethics committee and government agencies must also approve the clinical trial.
The new treatment being tested then has to go through a series of tests, known as Phases.
Sometimes, different trial phases may be combined, which can help speed up the development of a new drug.
Phase 1 trials
In phase 1 trials, a new treatment may be tested in 10-30 patients. The aim is to:
- Find a safe dose
- Check how often a treatment may be given
- Check for side effects
- See if the treatment has any effect on the cancer
Phase 2 trials
If the results of the Phase 1 trials are promising, researchers will use the information gathered from Phase 1 trials to gather more information in a Phase 2 trial. These trials involve more people (up to 100 patients) and could look at :
- Whether the treatment works well enough to continue testing it
- How safe the chosen dose is
- Side effects and how to manage them
- How treatment affects a person’s quality of life
If the results from a Phase 2 trial are good, the treatment moves to a Phase 3 trial.
Phase 3 trials
Phase 3 trials compare the new treatment to currently used treatments. The researchers could now be checking to see if the new treatment:
- Works better than current treatments
- Has fewer side effects
- Improves quality of life
- Has any problems researchers can learn more from to provide the treatment safely
If the Phase 3 trials show the treatment is safe and effective, the company that makes the drug can apply for a drug license and for it to be funded by each country’s healthcare system. Once the company has a license and is funded, the treatment can be prescribed for patients.
Phase 4 trials
Once the treatment has been approved, phase 4 trials continue to study its long-term safety and effectiveness.
Who can take part in a clinical trial?
Each clinical trial has strict criteria about who can take part. These are called inclusion and exclusion criteria.
Trial criteria usually include:
- Your age
- The type of cancer you have, including where it is located, how big it is, and whether it has spread
- Treatments you have had so far
- Whether you have other health conditions
Some clinical trials may require results from blood tests, scans, genetic tests, or biopsies. These are called screening tests. Your health team can look through the inclusion and exclusion criteria and help you understand if the trial is suitable for you.
How can I find a clinical trial?
Talk to your health team if you would like to participate in a clinical trial. They can help you find one suitable for you.
You can also find out about clinical trials on ClinicalTrials.gov, through our Clinical Trial Database or you can talk to us as we can help you find answers to your questions.