What are clinical trials?
Clinical trials are medical research studies involving people, both patients and healthy volunteers, which help establish whether a new treatment or procedure is safe and effective.
Which trials can I be involved with in New Zealand?
Hundreds of breast cancer clinical trials are underway internationally, and some of these are open to patients in New Zealand or Australian hospitals. There are also several locally developed clinical trials available.
Explore the clinical trials database to find a trial that suits you.
What kinds of treatments are tested in clinical trials?
Many trials test new treatments, but some also test new combinations of existing treatments, or new ways of administering existing treatments.
As well as adjuvant treatments, some trials focus on cancer prevention, some on stopping the spread or recurrence of cancer, and some on reducing the side effects of cancer treatments.
Trials may also investigate supportive care, dietary supplements or lifestyle changes like exercise programs.
Am I guaranteed to receive the new treatment?
No. Clinical trials compare a promising new treatment option with the current standard treatment. Usually the trial will be blinded, which means you won’t know whether you’re receiving the new treatment or not.
Clinical trials are the best way to ensure proposed treatments are safe and to find out which treatments work best.
Some types of clinical trials are designed to look at a treatment during its early stages of development. If the clinical trial shows the drug doesn’t work, or has serious side-effects, it might not be developed further.
Other trials look at drugs in the later stages of development. In these trials, researchers will find out about the benefits and risks of the treatment, so doctors can decide whether to use it, and how to use it.
Why should I participate in a clinical trial?
Clinical trials might allow you to have access to new treatments before they’re made available to all patients. These treatments typically go through eight to 10 years of development before they’re used routinely, so if a new treatment is effective, you could be one of the first to benefit from it.
Participating in a clinical trial also helps advance medical knowledge so that the best possible treatments can be offered in the future. Because of the participation of current patients, people diagnosed with breast cancer in the future may have a better chance of recovery.
Are clinical trials safe?
A possible treatment goes through years of development before clinical trials begin, and only the most promising treatments make it to clinical trials. The risks and safety procedures of a trial are carefully assessed, and all trials must be approved by an ethics committee before they begin.
That said, there are always risks. You might suffer worse side effects than those getting the standard treatment, the new treatment might not be as effective, or it might not work for you even if it works for other patients.
Before the trial begins, you’ll be informed of all the possible risks and benefits by a medical professional. When you’ve got all the information you can make a decision about whether or not you want to participate.
Can I quit the trial if I’m not comfortable with it?
Yes. You can remove yourself from a clinical trial at any stage if you’re not comfortable. Your doctor will then help you work out a new treatment plan.
Which clinical trials can I join?
All clinical trials have different eligibility requirements. Whether or not you can participate depends on a number of factors (e.g. your age, what type of cancer you have, which treatments you’ve had in the past, etc). These eligibility criteria help ensure the trial is safe for all participants, and that the researchers are able to find meaningful results.
You can read the eligibility criteria for each trial in the clinical trials database, and your doctor can help you work out which trials you’re eligible for.
Before you start a trial you may need to have some extra tests to make sure you’re eligible.
Can I participate in trials that aren’t in my area?
Sometimes. It often comes down to issues with safety or funding. No matter where the trial is based, it’s always worth asking your doctor about it.
If I travel to a trial, are my costs covered?
Occasionally funding from travel is covered by those running the trial. If you’re travelling from out of the local area, your DHB might fund your travel if the treatment is considered essential. You may have to pay for your own travel, but it is possible to apply for grants.
I’ve seen a trial on this database that I’m interested in, but my doctor hasn’t brought it up. Can I still participate?
Possibly. Get in touch with the coordinator of the trial you’re interested in, and ask them about your eligibility then discuss the trial with your doctor. You can find the contact details on the trial information pages in the clinical trials database.
What are the different phases in a clinical trial?
Clinical trials are carried out in two stages – an ‘early stage’ and a ‘late stage’. Early stage trials involve smaller numbers of participants and are used to fine-tune treatments before they’re tested on large groups. Late stage trials usually involve large numbers to test the effectiveness of a drug across a wide range of patients. Before either of these stages start, treatments must be extensively tested in the lab.
Early stage trials
- Phase 1
Phase 1 is the first stage and usually involves small groups of healthy people, or sometimes patients. This stage is aimed at finding out how safe a treatment is.
- Phase 2
Phase 2 trials aim to test the drug in larger groups of people to better measure the safety and side effects, and to see whether the drug has a positive effect in patients.
Late stage trials
- Phase 3
Phase 3 trials are large, and often involve hundreds, or maybe even thousands of patients, often from several countries. These larger trials aim to compare the positive effects of the drug to the current treatment, if there is one, and to find out whether the treatment works, and how long the effects last. They also help establish how common any side-effects are, and any possible long-term problems that could develop.
- Phase 4
Phase 4 trials are carried out after a new treatment has been shown to work, and has been licensed for use. These trials aim to find out how well the drug works when it’s used more widely, the long-term risks and benefits, and find any possible rare side effects.