My Breakthrough
Clinical trials
Research plays a vital part in finding new and better ways to treat and care for people with cancer. It can also show what doesn't work or may be harmful.
A clinical trial is a study that is carried out in people (as opposed to laboratories).New cancer treatments are usually tested first on people who have already tried most or all of the treatments that are already available for their cancer.
It's entirely up to you whether or not you take part in a clinical trial. But, if you are thinking of getting involved, you may be asking some of these questions:
- What is a clinical trial?
- Why do we need clinical trials?
- How is a clinical trial planned?
- What procedures do researchers have to follow?
- How do I know that the trial is ethical?
- What type of trial is it?
- Can I join a clinical trial?
What is a clinical trial?
- A new test, such as a new blood test or scan, which may be useful to diagnose an illness or monitor treatment.
- A new treatment, compared with an older, accepted treatment to find out which is better. In cancer this may mean comparing drugs, radiotherapy or different operations.
- The way a treatment is given. For example, comparing how frequently drugs are given - once a week, once a month or continuously.
- A new method of care. For example, a new way to relieve symptoms, such as pain, nausea or shortness of breath, that can improve your everyday life and activities.
- Researchers use different methods to answer different questions, for example randomised trials.
Why do we need clinical trials?
Doctors will have been using the results of earlier clinical trials to advise you what treatment is best for you now. The results of today's trials will help shape the way cancer is treated in the future.
How is a clinical trial planned?
- It must be ethical. This means it must be planned and carried out according to national and international guidelines on what is morally right.
- It must be scientifically sound so that it produces accurate results which answer the research question. These results must be reliable so they can be used in future.
- As far as possible, any foreseeable risks must be no greater than the risks of the present treatment. The risks must be worthwhile for each person, including the risk of having no treatment (i.e: being in a placebo group).
The main concern about any trial is that it is suitable and safe for patients.
Trials need a team effort to make sure they are successful. If you decide to take part, you are an essential member of this team. You must be given all the information you want, you must understand what will happen, and you must freely agree to take part.
Points which your doctor or the researcher should discuss with you include:
- What type of trial this is, why it is being done and how it has been planned.
- How the research affects you, for example how long the trial will last, any extra tests or hospital visits that you will need.
- The meaning of the words and phrases that are used.
- What is known about the benefits and risks of the treatment you may be given in the trial, and how these compare with those of treatments that are already available.
- The safeguards which exist to protect you.
- Who you should contact if you have any concerns or problems.
- How to find out the results of the research, if you would like to know.
What procedures do researchers have to follow?
A protocol is a plan of the trial giving the reason for doing the research. It includes the background to the technique, treatment or problem and all the information currently available. Also included are details of how the study will be carried out and how the results will be analysed.
The protocol is put forward for independent scientific review. This is a review of the method to be used and how the results are to be obtained, including the checks to be carried out and the strength of the statistics. The protocol is then passed on to a Research Ethics Committee.
How do I know that the trial is ethical?
The REC is made up of doctors, scientists, nurses and non-medical people, such as lawyers or people from a Community Health Council.
If a trial is thought to be inappropriate or unethical, approval won't be given and the research won't go ahead. The REC can ask for changes to the trial. Once a trial has been approved, the researcher must ask permission before it is changed in any way. Unexpected or serious events must also be reported to the REC.
At the end of the trial the Committee will require a summary of results, including any problems such as difficulty recruiting people to the study. The REC may also ask for copies of published articles based on the results of the trial.
The REC requires the researcher in charge of the trial to explain the project to you and to obtain your written consent before including you in the study.
What type of trial is it?
Some of the procedures may appear to be complicated. But doing trials in this way ensures that the results are reliable and worthwhile, and that you are protected during the study.
Before a new anti-cancer drug gets a clinical trial, it will have been tested in laboratory studies. These will have proved that the drug can kill cancer cells and given some information about its possible side effects.
There are three stages for testing a new anti-cancer drug in clinical trials:
Phase 1 studies
These are designed to find out:- What is the most effective dose of the drug and how much can be given safely, for example the maximum dose and how often the drug can be given.
- Whether enough of the drug is circulating in the blood, after it is given, to kill cancer cells.
- The side effects of the drug.
There are two problems in this type of study:
- People who get the lowest dose may not benefit from the new drug.
- People who get bigger or the biggest doses may have more side effects.
Doctors try to raise the dose as quickly and safely as possible while avoiding unnecessary side effects.
If it is thought that the new drug may be active against particular cancers, patients with those cancers will be selected for a Phase 1 study. However, finding out which cancers respond best to the drug is the main aim of a Phase 2 study.
Phase 2 studies
Doctors use the information gathered in a Phase 2 study to decide:- The dose of treatment.
- How often it should be taken.
- The particular cancers which may respond best to the treatment.
Several phase 2 trials will be carried out on different cancers so that doctors can find out how active the drug is. Only about 20 patients with each cancer are needed to take part in this early work. They will be watched very carefully for the effects and side effects of treatment using regular check-ups, blood tests, x-rays or scans. If the drug doesn't work, no more trials will be carried out. But if a good response is seen, the doctors will design a Phase 3 study.
Phase 3 studies
A phase 3 study usually compares a new treatment with the best treatment currently available. The aim is to find out:- The effect of the new treatment on the cancer, as compared with the current best known treatment.
- How long the effect lasts.
- The side effects of the new treatment.
- Any possible longer term problems which could develop.
If the differences between the new treatment and the existing treatment are small, hundreds of patients may be needed to show which treatment is best. Patients may be needed from several hospitals, not just in the UK but also in Europe, America or other parts of the world.
Phase 3 studies are usually randomised trials and may include a double-blind procedure (see types of clinical trials).
Can I join a clinical trial?
Also within "Understanding breast cancer"
