Clinical Trials Q & A's
What is a clinical trial?
A clinical trial is a
study designed to answer specific questions about new
medications or therapies for a specific health
condition such as asthma, COPD or lung cancer.
Clinical trials are used to determine whether new
drugs or treatments are both safe and effective, and
are the fastest and safest way to develop new
treatments that work for people.
If I am randomised, what does it mean?
Randomisation is the allocation of of participants to either the placebo or active treatment group, and is done by chance (like flipping a coin). Study participants cannot choose whether to take the active drug or placebo. It is used to eliminate the possibility of bias.
What does "placebo-controlled" mean?
A placebo is a dummy treatment, such as sugar tablet or saline which looks, smells and tastes exactly like the real thing but contains no active ingredients. The placebo-effect is a well known phenomenon where people being closely monitored or studied tend to feel better because of the attention they receive and the belief that they are being treated. The placebo effect can be very strong so the effects of a new drug must be proven to be greater than this.
Placebos are used in clinical trials to show that any effects that are measured during a trial really are due to the drug being studied. Participants in a trial will not know whether they are taking the real drug or the placebo and usually neither will the study staff.
Placebo-controlled trials are considered the gold standard and therefore most Phase I, II and III trials will include a placebo group.
What does "double-blind" mean?
This means that neither the staff running the study nor the study participants know whether they are taking the real medication or the placebo. It is used to eliminate bias by ensuring that neither the participant nor the study staff are influenced in their interpretation of the study results.
At the end of the study, the "blind" is broken to reveal who was taking the active treatment to allow conclusions to be drawn about the drug effectiveness and safety. In an emergency, the study doctor is able to find out which treatment a person is taking.
What will I be asked to do?
Depending on the type of
study, you will be asked to do different things, but
the most common things are taking your medication as
it is prescribed, attending visits at the clinic at
pre-arranged times, keeping a daily diary of your
symptoms, and ensuring that you contact us immediately
if you are unwell or have any concerns.
How long will I be on the study?
Some of our studies only
go for a month or two, and others last for up to a
year. You will be told how long the study lasts the
first time you contact us for information about the
trial. The number of visits to the Unit's clinic can
also vary quite a bit, some studies have a visit every
week, and others might be every few months.
What if I need to change an
appointment?
We will try and book all
your visits when you first come in to see us, so that
you can plan in advance. However, if you need to
change an appointment, simply call the Unit as early
as possible and we will try to reschedule.
What if I change my mind about being
in the study?
All of our studies are
voluntary, so you can decide not to participate and
you don't have to tell us why. Even if you join the
study, you can still change your mind and withdraw at
any time. Again, you don't have to give us a reason,
but we may ask you to come in for a final visit to do
some safety checks.
What if something happens to me while
I am on the study?
Monitoring new
medications to ensure that they are safe and have few
side effects is an important aspect of any clinical
drug trial. During the study you will be regularly
assessed for any potential side effects of the study
drug. You should always contact the Unit's clinic if
you think you are experiencing side effects. If they
are severe enough, the doctor may temporarily stop
study medication, reduce the dose, or withdraw the
medication completely. In the unlikely event that you
become unwell from taking part in this trial, you will
be provided with the necessary medical care at no
cost.
Will I be paid for being on the
study?
While we are unable to
provide payment for participation on a trial, we can
usually offer reimbursement for your travel expenses.
Depending on the trial, if the visits are very long
you may be provided with a meal and compensation for
lost time and inconvenience.
What are some of the procedures I
might be asked to do?
Common procedures you
will be asked to do include:
• Physical
examinations and vital signs (blood pressure, heart
rate and breathing rate measurements);
•
Electrocardiograms (ECG), which are electrical
recordings of how your heart is working. This
procedure does not hurt;
• Lung function
measurements, which will be done with a machine called
a spirometer. You are asked to breathe into a
mouthpiece and this will measure your lung capacity;
• Questionnaires about your health problems and
general well being;
• Blood samples are commonly
required and we usually need about 10 mls (4
teaspoons). This is taken from a vein in your arm.
Occasionally some trials require multiple blood tests
during the same visit;
• Urine samples are often
collected for routine urinalysis testing. You will be
asked to provide a sample during your visit;
•
Pregnancy tests, if you are female and of child
bearing potential, your blood and urine samples may
also be used to test for pregnancy. It is very
important that you do not become pregnant during a
study, so if you are thinking of becoming pregnant, or
are breast feeding, you will not be able to be
involved in a clinical trial; and
• In some
studies chest x-rays or CTscans, may be required to
ensure that your lungs are otherwise healthy. These
tests do not hurt.
Can I be involved in more than one
study?
You can only be on one
clinical trial at a time; however you would always be
welcome to join another study after you have finished
a trial.
What does it mean if I am not
eligible for a study?
Because we want to
ensure that the data we gather about a new medication
is as accurate as possible, we select participants
using eligibility criteria that will ensure we get the
best answers. So the best matched participants are
chosen for the right trial, the rules are often strict
and may factor in age, other medical conditions, or
how good or bad your lung function is. If you are not
eligible for a study it does not mean that you have
‘failed', and you may always be eligible for another
study.
Can I tell people that I am on a
clinical trial?
It is your decision if
you want to tell people that you are on a clinical
trial. We encourage you to speak with family and your
doctor if you are considering participating in a
study. However, we will keep all your information
confidential. | 
