Understanding Clinical Trials
Cancer clinical trials include research at three different phases
Each phase answers different questions about the new treatment.
Phase 1
- The first study that involves people
- Looks at how a new treatment should be given (e.g. by mouth, IV drip, or injection?), how often (e.g. how many times a day?) and, if it involves medication, what dose safe is safe
- Only involves a small number of people
Phase 2
- Continues to test the safety of the treatment
- Assesses how well the new treatment seems to work (e.g. does the tumour shrink? Does it improve blood test results?)
- As in Phase 1 only involves a small number of people
Phase 3
- Compares a new treatment to the best standard treatment, to work out which is best (e.g. which group has better survival rates? Fewer side effects?
- Studies move into Phase 3 testing only after a treatment shows promise in Phases 1 & 2
- Assigns people at random to receive the new treatment or the best standard treatment
- May involve hundreds or thousands of people from around the state, country or world
Clinical trials benefit both patients and the community at large
Patients involved in clinical trials receive up-to-date care from cancer experts. They receive either a new treatment being tested or the best available standard treatment for their cancer.
Clinical trials contribute to knowledge and progress against cancer. If a new treatment proves effective in a study, it may become a new standard treatment that can help future patients. Because of progress made through clinical trials, many people treated for cancer are now living longer, and experience less side effects from their treatment.
In the past, clinical trials were often seen as a last resort for people who had no other treatment choices. Today, it is becoming more common for people living with cancer to receive their first treatment enrolled in a clinical trial.
Randomised Controlled Trials
A controlled trial compares a new treatment with the current best standard treatment (the control). In a randomised controlled trial, some people receive the new treatment while others receive the standard treatment.
If you take part in a randomised trial, you will receive one of the treatments being compared in the trial. Your treatment will be chosen by a computer which randomly assigns people to each group. This is done so each group has a similar mix of people- to ensure the people getting each treatment can be compared without bias. Neither you nor your doctor can choose which treatment you will receive.
Blinding and Placebos
If you are involved in a trial of a new drug, you and your doctor might not be told which treatment group you are in. This is known as blinding, and is used to eliminate bias in a trial.
Blinding is done by making medicines look the same so that they cannot be told apart. Sometimes this involves placebo (dummy) tablets or injections that look the same as the experimental treatment but don’t contain the active ingredient.
How much does it cost and who pays?
Clinical trials are usually funded by research funding organizations or by companies that produce the treatments being tested, like drug companies.
Some of the tests and treatments involved in a trial are part of standard care. The cost of any extra tests or treatments that are not part of standard care are covered by the trial organisers.
Cancer trials take time and money. Research funding is limited and competition for funds is fierce. Fewer than one in four research proposals get funding and many trials are not adequately funded.
