Randomised controlled trials
A clinical trial is a medical study involving patients who
volunteer to take part. Clinical trials are used in all areas of
medicine and are carried out for many different reasons. They could
be testing a new treatment by comparing it to the best current
treatment available or they could be used in testing new technology
or procedures.
From clinical trials we can find out if a new treatment is safe,
if it is better than the current treatment and we can find out what
the side-effects of the treatment are.
Types of studies
Treatment Trial
There are many different types of trials. The most common type of
trial is a
treatment trial. These look at the best
way to treat a medical problem. They usually involve testing new
drugs, new combinations of drugs or new ways of giving
treatments.
Quality of Life Studies
These studies look at how a disease and/or treatments can affect
your daily life. Many large treatment studies also include a
quality of life study. Quality of life data is sometimes called
Patient Reported data.
Randomisation
When we do not know which way of treating patients is best, we need
to make a comparison. An important part of making a fair comparison
is “randomisation”. Most large trials are randomised. Patients
taking part are randomly allocated either the standard treatment or
the research treatment. This process is essential to avoid
bias: if the groups of men receiving each treatment are the same,
any differences in the results can only be down to the treatments.
Therefore, randomisation means that the results are more reliable.
The process of randomisation is usually carried out by a
computer-based system.
Should I take part in a trial?
Like any decision you make, deciding to take part in a clinical
trial needs to be made as an informed decision based on the
evidence made available to you by your doctor. There are both
benefits and risks to taking part in a clinical trial so you should
take your time in making the decision and consider some of the
points below.
The possible benefits of being in a trial include:
- getting a new treatment that might work well and that you could
not get outside the trial. However new isn’t always better!
- helping to improve cancer treatment for future men like
you
- having more tests, scans or check-ups which you may find
reassuring
To weigh against these benefits, there are also risks:
- a new treatment may have side-effects that are not yet known
about. You would be closely monitored and your study treatment
would be stopped if necessary. It is important to remember that
treatments have been very carefully researched in the laboratory
before being given to patients and there is a lot more known about
treatments in phase III trials than in phase I and II trials.
Studies also have to be approved by an independent Research Ethics
Committee
- some people also find that they have to make more trips to the
hospital which can be inconvenient
- there is a chance that you could be asked to complete some
paperwork, such as quality of life forms. These are really useful
for the research may but may be burdensome to complete
Will I be asked to join a trial?
You may be approached by your doctor about the possibility of
participating in several different clinical trials. You should make
sure the trial is suitable for you.
RADICALS is a randomised clinical trial that has been designed
for men who have had a radical prostatectomy.