About Clinical Trials
This section contains information on the following:
What is a Clinical Trial?
Why are Clinical Trials important in ovarian cancer?
Should I join a Clinical Trial?
What are Clinical Trial phases?
Who conducts Clinical Trials?
How are Trials funded?
Personalised medicine and targeted treatment
About Clinical Trials
Clinical Trial Phases
Trials involving humans (known as ‘clinical trials’) are done in several steps, called ‘phases’. There are five main phases (0 through 4).
In the table below, we discuss clinical trials involving drugs. Clinical trials testing other ways of treating cancer can also follow these phases.
| Phase | What it tests | Participants | What happens |
|---|---|---|---|
| Pre-phase (lab testing) | The safety of the drug before human trials | Animals | The drug is tested first in the lab and on animals, to check for safety. |
| Phase 0 | How the drug behaves in the body and if it will affect cancer cells | Small group (usually fewer than 15 people) | Very low doses are used to see how the body reacts. Extra tests like blood samples and scans may be done. The drug isn't expected to shrink the cancer yet. |
| Phase 1 | How much of the drug can be given without harmful side effects | Small group | Drug doses start small, slowly increasing to find the safe and right amount. Researchers check for side effects and how the body handles the drug. Some people might benefit, but not all. |
| Phase 2 | Whether the drug works, what cancers it could treat and whether side effects are manageable | Larger group and the trials are sometimes randomised | More people are tested. Researchers study how well the drug works, how to manage side effects, and the best dose to give. Some people might see improvements, but others may not. |
| Phase 3 | Whether the new drug works better than current treatments and has fewer side effects than current treatments | Large group and the trials are usually randomised | This is a big trial to compare the new treatment with current treatments. It looks at how the drug affects quality of life and overall success. |
| Phase 4 | Long-term effects and how well the treatment works in everyday use in people with cancer | Large group (thousands) | After the drug is licensed, researchers study the long-term benefits and risks, including rare side effects. This happens once the drug is approved and available for general use. |
Why are these phases important?
Each phase of a clinical trial helps researchers build more information about how a drug or intervention works and whether it is safe. For patients, this process can mean having the chance to access new treatments that may be effective in treating their cancer.
You can see why clinical trials take time and why it is so important to conduct studies that are focused on finding better treatments.
Your participation in any phase of a clinical trial will help researchers improve cancer care for everyone.
Who conducts Clinical Trials?
Clinical trials are run by doctors, researchers and other health professionals who are trying to find better ways to treat cancer. They can take place in hospitals, health clinics (including general practices), specialised cancer centres and universities. Sometimes they are supported by drug companies or the Department of Health. Sometimes several organisations and hospitals will work together on the same trial.
How are Trials funded?
Clinical trials are funded by different groups who want to help improve cancer treatment. These can include government health organisations, cancer charities, research foundations, universities and pharmaceutical (drug) companies. Sometimes, several of these groups work together to support a trial.
Funding helps cover the costs of running the trial, including tests, treatments, staff and follow-up care. No matter who pays for the trial, it must meet strict safety and ethical standards to protect the people taking part.
Personalised medicine and targeted treatment
Historically, cancer treatment has had a ‘one size fits all’ approach. Treatment for ovarian cancer has generally involved surgery with chemotherapy before and/or afterwards.
Each person has their own genetic makeup. We now know that individual cancers can also have an individual genetic makeup. This means that people can benefit from treatments that target their specific cancer. This is called ‘personalised medicine’.
Personalised medicine is a growing area of ovarian cancer research and treatment. It involves gathering information on someone’s individual inherited genetics, or the genetics of their cancer, to better guide treatment decisions.
Targeted therapies are designed to target cancer cells, to try to reduce side effects and improve results. Some of these treatments target genetic variants in cancer cells.
Programs available around Australia are looking at an individual’s ovarian cancer to try and identify features that can guide treatment choices, and options to join clinical trials.
For more information on personalised medicine and targeted treatment, visit our page here.
Helpful Definitions
What are Clinical Trials? - Clinical Trials Alliance Australia
Clinical Trials, summarised
Clinical trials help researchers find better treatments for ovarian cancer.
They test new ways to prevent, detect and treat cancer, and improve quality of life and side effects.
Joining a clinical trial may give you access to new treatments and help others in the future.
Not everyone can join any trial – ask your doctor whether there is a trial that will suit your situation.
There are different types of clinical trials:
Treatment trials test new drugs or ways to use current ones.
Prevention trials look for ways to stop cancer from coming back.
Screening trials aim to detect cancer earlier.
Quality of life trials help manage symptoms and improve comfort.
Genetic trials study how genes affect cancer and treatments.
Observational trials track people over time without changing their treatment.
Clinical trials are done in phases:
Phase 0: Tests how a drug behaves in the body (very early).
Phase 1: Focuses on safety and finding the right dose.
Phase 2: Looks at how well the drug works.
Phase 3: Compares the new drug to the current standard treatment.
Phase 4: Studies long-term effects after the drug is approved.
Some trials are randomised, meaning people are placed into groups by chance to make the results fairer and more accurate.
You might not know which treatment you are getting – this is called a ‘blind’ trial.
Personalised medicine uses your genetics to choose the best treatment for you and tailors your treatment to you.
Even though not every trial leads to a new treatment, they are an important part of improving care and offering hope for better outcomes in the future.
Videos about Clinical Trials
• Lived experience video, Ovarian Cancer Australia https://www.ovariancancer.net.au/clinical-trials
• What are clinical trials? Australian Clinical Trials Alliance https://www.youtube.com/watch?v=maiVZ54nUYM
• Latest developments in ovarian cancer, Ovarian Cancer Australia https://www.ovariancancer.net.au/clinical-trials
• Clinical trials videos, American Cancer Society https://www.cancer.org/cancer/managing-cancer/making-treatment-decisions/clinical-trials/clinical-trials-videos.html
Further Support
Life will be different following a diagnosis of ovarian cancer: the effects of the disease and its treatment can present all kinds of unique challenges. If you are thinking about taking part in a clinical trial, you may need extra support and information to help you make this decision.
Many people and organisations can provide you and your family with information and support to make the journey a little easier: support groups and online forums provide friendship, inspiration and laughter, and other services can help with finances, meals, childcare and cleaning.
Ovarian Cancer Australia can help you find support.
Nurse Helpline
If you or someone you love has been diagnosed with ovarian cancer, you can contact us on our Helpline 1300 660 334 and speak to one of our ovarian cancer support nurses who can assess your situation and suggest which programs and/or services might be suitable to your individual needs. They can also give you general advice about clinical trials and suggest where you can go to find further information to meet your individual needs.
Call 9 am – 5 pm Monday to Friday 1300 660 334 or email support@ovariancancer.net.au.
Visit Helpline for more information about our Helpline.
Your Ovarian Cancer Teal Support Nurse
The Teal Support Program provides women with their own ovarian cancer nurse specialist, no matter where they live. This free service, delivered via telehealth, provides support for those with ovarian cancer throughout diagnosis, treatment and beyond.
For more information, visit: Teal Support Program
Support groups and networks
Support groups provide the opportunity to share experiences, receive emotional support and be informed. This can also include finding out about clinical trials and speaking to other women who are taking part in trials or looking for a trial. Joining a support group can give you a valuable opportunity to share your experience of navigating treatments and decision making.
A support group can be a safe space where people their experiences with treatments. Many people feel they need to talk to someone who really understands their situation and ‘speaks the same language’. The right support group can provide you with this.
For more information, visit: Online support groups
