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65 OR OVER? BECOME A PAIDVOLUNTEER AT COVANCE, LEEDSStep by step
guide
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Staff are friendly, helpful and always have a smile.Marilyn, Age
65, Leeds
Becoming a clinical trial volunteer wasn’t my first thought on
turning 65.Making a difference and earning up to £100 a day
was.
Are you 65 or over? Then you could join our team of paid
clinical
trial volunteers to play a part in developing new or
improved
medicines and earning from £100 per day. In addition, you
receive a free comprehensive healthcheck.
Taking part in a clinical trial is a serious but rewarding
decision.
As a paid volunteer, you’re helping develop life changing
medicines for conditions like asthma, Alzheimer’s and
Parkinson’s disease.
It’s also a great way to meet like minded people and enjoy
being
looked after.
After reading this booklet, you’ll know more about becoming
a
paid clinical trial volunteer.
Covance is one of the biggest Contract Research Organisations
(CROs) in the world with over 10,000 employees in over 60
countries, working with Pharmaceutical and Biotechnology companies
from across the globe to develop new and better medicines.
It takes 12-15 years andaround £100 million to developjust one
new medicine.
WHAT ARE CLINICAL TRIALS?
Clinical trials are a type of medical research that involves
both
people with a medical condition and healthy people to test
new
medicines and treatments. They are used to collect scienti�c
data
to answer speci�c questions like if the medicine works as
expected, what doses are needed and if there are any side
e�ects.
The more trials that are run, the more can be understood
about
the medicine.
The treatments could help people to survive a life
threatening
illness, for example a blood infection, or improve the quality
of
life for people with long term conditions, such as chronic
pain,
perhaps by o�ering a medicine with less side e�ects than the
current options.
WHAT TYPES OF TRIALS DO COVANCE LEEDS RUN?
Covance Leeds run two types of trials:
• First-in-Human (FIH) trials - the �rst time a test medicine is
given to people
• Labelling trials - providing information on the medicine label
or to help the prescriber, for example if the medicine should
be
given with food, if the age of the patient will a�ect the
amount
of medicine needed or if it might a�ect any other medication
the patient might be taking at the same time
The clinical trials in the Leeds clinic tend to run from a few
days
to a few weeks. Occasionally we have studies that may last a
couple of months, however as the clinic performs mainly
early
stage development trials in small numbers of healthy
volunteers
or patient groups, they tend to be quite short in comparison
to
the later stage trials which look at long term bene�ts of a
medicine.
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First-in-Humantrials (FIH)
Types of trialsat Covance Leeds
Labellingtrials
I met lots of new friends and spent my time relaxing and playing
darts.Dave, Age 65, Leeds
HOW DO CLINICAL TRIALS WORK?
Highly trained and experienced Doctors, Scientists and
Statisticians design a clinical trial to
answer speci�c research questions. They will look at other trial
designs that have been previously
conducted to generate the most e�cient design to collect data to
answer the research questions.
This design is known as the ‘protocol’ which is the instruction
document to explain how the trial
will run.In order to conduct the study the protocol must be
approved by both a government
regulatory body and an NHS ethics committee.
WHY DO WE HAVE CLINICAL TRIALS?
Clinical trials are the only sure way to understand how new
medicines will work in people and are
required by governments around the world. The information from
the clinical trials is used to help
the Doctors and Scientists develop the most e�ective treatment.
All new medicines have to go
through a number of di�erent stages of development called
‘phases’ to get the approvals needed for
patients to receive it.
Covance Leeds hashelped develop
246new medicines inthe last 10 years
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8000 people took part in a clinical trial involving healthy
volunteers last year in the UK
HOW DO CLINICAL TRIALS HELP THE DEVELOPMENT OF NEW
MEDICINES?
Each new medicine must be approved by the government of each
country in which it is intended to be used. The government
departments that make this decision need to be provided with
evidence that the medicine is safe and has a health bene�t.
Conducting scienti�cally designed clinical trials is the only
way
that this information is generated to enable the approval of a
new
medicine for use. A new medicine will only be approved for
use
if:
• It is safe and works e�ectively
• It is a brand new treatment for a particular disease or it is
a better treatment than the ones that already exist
• It causes fewer unwanted side e�ects in patients WHAT KIND OF
PEOPLE TAKE PART IN CLINICAL TRIALS?
Di�erent people take part in di�erent Phases of clinical
trials.
The early development studies often involve healthy
volunteers
and the later phase studies involve people with medical
conditions (generally with the condition the medicine is
intended
to treat). The people who can take part are de�ned in the
trial
protocol in the eligibility criteria section. As these inclusion
and
exclusion parameters, such as age or medical history,
ensures
that the trial is safe and no volunteers are exposed to
avoidable
risks, it may limit the trials that you can take part in.
By undertaking screening tests, we can understand which of
the
trial criteria are a match for you. For example, if a potential
side
e�ect of a new drug is that it increases blood pressure you
may
have your blood pressure assessed to check if the trial will be
safe
for you.
However, if you do not qualify for a particular study it
doesn’t
mean that you are unhealthy; it is just that particular trial is
not
right for you.
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I like to think I’m doing my bit helping make medicines
better.Margaret, Age 65, Leeds
HOW ARE PEOPLE RECRUITED ONTO CLINICAL TRIALS?
Covance Leeds has a dedicated team of volunteer recruitment
specialists based at the clinic
who manage our database of potential volunteers so we can
contact them when a suitable trial
is available for them. Our team is aware of all the trials that
are available at the clinic and can
answer any questions you might have about taking part in a
clinical trial or refer you to one of
our Covance Doctors if you require speci�c medical
information.
All information is held on a voluntary basis so if at any point
you would like to no longer be
contacted, just let us know and we can update our database.
WHAT ARE THE RISKS?
Like most things in life, participating in clinical trials can
carry some risk that no one can
really predict. While any predictable risks are minimised
through careful planning and
design, there may be side e�ects that the doctors and scientists
were not anticipating. These
are often short-lived feelings such as nausea or headaches. As
part of the clinical trial process,
you will be given all the information that the researchers know
about potential risks or the
likelihood of sides e�ects.
During a trial, your wellbeing is the number one priority to
Covance Leeds sta�. You will be
monitored regularly throughout the trial and will have constant
access to our experienced and
friendly medical team who will perform routine assessments to
check on your health during
your stay.
In addition to the payment you receive in return for the time
you commit to the trial, you
undergo a free thorough medical check up which is reassuring and
could be of real bene�t to
your health if something is picked up and treated quickly.
However most importantly, you are
helping to develop new medicines for people who really need
them.
Taking part in a clinical trial is a great thing to do, both for
yourself and for the bene�t of
future patients. However like most extraordinary things,
clinical trials aren’t for everyone.
What you need to think about is whether the potential risks
outweigh the bene�ts to you.
73%of volunteersdo furtherstudies
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WHAT HAPPENS IF SOMETHING GOES WRONG?
It is highly unlikely that anything will go wrong when taking
part
in a clinical trial, however every trial must have arrangements
in
place in the rare event that something does. Some people do
react
badly to some medicines, including those already prescribed
by
doctors. No one is really sure why, and it cannot be predicted,
but
it is very rare and with the right sta� and equipment present
the
symptoms can easily be treated. In such cases immediate
medical
care is provided by the clinic and the local hospital if
necessary.
WHY DO I GET PAID?
The early stages of drug development need healthy volunteers
to
provide accurate information about the properties of a new
medicine. If people with a medical condition were used at
this
stage, their condition often a�ects the quality of the study
data
therefore making it hard for the Doctors and Scientists who
are
developing the drug to make the right decisions. Healthy
people
don’t need to take a medicine, so we pay you for the time
you
spend on the trial and the inconvenience it causes to your
normal
daily lifestyle.
It is highly unlikely that anything will go wrong.
Time spenton trial
Change of dailyroutine
Inconvenience Payment
More time, inconvenience and changeto routine means a higher
payment
£
£
£
£
£
£
£
£
£
Each clinical trial will have di�erent requirements in terms of
the assessments performed;
how long you need to stay in the clinic and the restrictions you
might need to adhere to, for
example refraining from strenuous exercise and drinking alcohol
for a week before the
study or following our detailed timetable of assessments and
activities like the times you
can eat and go to bed.
You are paid for this inconvenience and commitment of your time
i.e. the more complex
and the longer the trial lasts, the more you are paid because
you have to commit more time
to the trial and be inconvenienced for longer. It is important
to note that you are not being
paid because the trial or the new medicine is “risky”, the
scientists and clinicians designing
the trial do so with aim to reduce any risk as much as possible.
The study payment is simply
to compensate you for the time and inconvenience you will
experience by participating in a
clinical trial.
By contrast, in the later clinical trials such as in Phase 3, it
is normal for patients not to be
paid for their participation because their health can
bene�t.
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I got a free healthcheck which wasreassuring and I earnt myself
some money too!Tom, Age 73, Leeds
YOU GET A FREE HEALTH CHECK
+CAN I CHANGE MY MIND?
Yes. Clinical trials are entirely voluntary so you can stop
your
involvement at anytime. However, if you do decide you no
longer
want to take part, your payment may be a�ected.
REASSURANCE AT EVERY STEP
We understand that taking part is a big decision. That’s why
our
friendly team has all the information to answer your
questions
and put your mind at rest. Whether you’re asking about the
tests,
how long you’ll need to stay or what facilities we have our
team
can help. If you’re close enough, you can even pop in for a
tour.
THE BENEFITS OF BEING A PAID VOLUNTEER
There are many reasons why people choose to take part in
Covance clinical trials. Besides being a great way to boost
your
income, you’re helping the medical profession develop
pioneering treatments for conditions like diabetes and
Alzheimer’s.
With plenty of free time, it’s a good way to relax and meet
like
minded people. Taking part is simple, it just takes a little of
your
time and you can earn from £100 per day.
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TAKE A TOUR OF A TYPICAL CLINICAL TRIAL AT COVANCE, LEEDS
Getting started
The �rst thing we do is a thorough health check called a
screening visit. This
is routine and only takes a couple of hours at our Leeds clinic.
Simply book an
appointment that suits you and we’ll even reimburse your travel
costs.
Our comfy Screening Reception has the latest newspapers and
celebrity
magazines, as well as plenty of TVs and PCs where you can surf
the web while
you wait.
You’ll need to bring some photo ID like your driving license or
passport and
you may have to prepare by cutting out alcohol and exercise. But
don’t worry,
we’ll let you know the details beforehand. We will even send you
reminder
texts so you don’t forget.
Your Permission
Before you go any further we need your consent. That’s why one
of our highly
skilled doctors will talk you through everything. We’ll also
give you lots of
information to read through and discuss with your family and
friends before
your screening visit. This is to make sure you’re happy with the
trial you’ve
chosen and the screening process. If you’re satis�ed, you can
then sign an
‘informed consent’ form. This is your written permission for us
to carry out
the screening tests and later, the trial. Don’t worry, you can
change your mind
and stop taking part in the trial at any point.
Your Free Health Check
Your free health check or screening visit is very thorough.
First we chat
through your medical history, then give you a physical
examination.Here we’ll
record your height, weight, blood pressure and heart rate.
One of our nurses will test your heart function using an ECG
machine, as well
as taking blood and urine samples. And yes, there will be
needles. Our team
will do all they can to put you at ease but if you’re not keen
on giving blood
samples, maybe this isn’t for you.
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The Green Light
A couple of days after your assessment we’ll let you know
whether you’re suitable. If not, don’t worry. Each study has
speci�c criteria and even if you’re in tip top condition
something as simple as a recent holiday jab can a�ect your
suitability for a particular trial. But please try again,
because in a couple of months you could be just what we’re
looking for.
The Big Day
Each trial needs a little bit of preparation. We’ll send you
all
the details well in advance. Our friendly team will also
call
you to remind you of all the things you need to do or bring
with you. It’s usually things like no alcohol beforehand.
Strenuous exercise like aerobics or swimming can also be
o� limits.
Checking-in
When you arrive you’ll be greeted by our friendly clinical
sta�. Just to make sure you aren’t bringing alcohol or
snacks with you we’ll have a quick look in your bags. It’s
very important that you stick to study guidelines, if you
don’t, it unfortunately means we can’t use your results.
Getting Settled
Once you’ve checked in we’ll introduce you to the team
who’ll be looking after you and then we’ll show you to your
bedroom. You’ll share this room with at least six other same
sex volunteers, so there’ll be plenty going on and if you
don’t want to join in you can pull the curtains round, dip
into a magazine or a good book.
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Up and Running
We’ll wake you bright and early on the morning of your trial
and after a few more medical checks you’re ready to start.
It’s
so easy you don’t even have to get out of bed for these, just
sit
back and relax.
Taking the Study Drug
Taking the study drug is a very important part of the
clinical
trial. Our experienced nurses will give you the study drug
and tell you everything you need to know.
Regular Samples
The �rst dosing day is pretty busy. We’ll often take samples
of blood and urine usually to a set time frame, also, many
doctors and nurses will visit you throughout the day to note
down how you’re feeling. Some days are busier than others,
it depends on your trial and how long you’re staying.
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Waited On Hand and Foot
Whilst you’re here you can look forward to a great range of
tasty meals freshly prepared in our kitchens by the Covance
chefs. These tasty dishes and desserts are brought to your
table in our dining room by friendly waitresses. We’ll even
do
the washing up.
Your Free Time
There’s plenty to do when you aren’t being monitored. Our
Recreation O�cer always has something planned like card
games and quizzes to get your brain going. You can also
settle down to Sky Movies and Sky Sports which means
sports fans don’t miss a game.
We’re also kitted out with PCs and fast Wi-Fi so you can
check your emails, Skype friends and family, catch up on the
news or even download the latest best seller on your Kindle.
And for something altogether di�erent, there are language
courses and craft workshops too.
All Done
Here comes the easy part. Because every trial is di�erent
you
could spend just a couple of days in the clinic, a week or
even
longer. We’ll check you over before you leave and after any
return visits are �nished you’ll have a �nal check-up which
marks the end of your trial. And here’s the best bit, you
receive your cheque before you leave.
If you enjoyed your stay with Covance and liked its earning
potential even more, why not boost your income yet again by
recommending us to a friend or relative. It’s easy, for
every
person you recommend who goes on to attend a screening
visit you’ll be �nancially rewarded again.
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We need more peoplelike you to volunteer
WHY DO WE NEED MORE PAID VOLUNTEERS?
Every day we trial drugs to improve conditions like asthma,
Parkinson’s and even hay fever. As an existing volunteer you
can
help us spread the word and be rewarded for passing on the
opportunity to your friends and relatives. They simply
choose
from a range of studies available and remember, the longer
their
stay the greater their earning potential. It’s simple.
HOW CAN I FIND OUT ABOUT TRIALS I CAN TAKE PART IN?
Covance Leeds provides ‘trial listings’ to our volunteers on
the
database. You can register for the volunteer database online
our
call our recruitment team on 0800 591 570 or 0113 394 5200.
We also detail our current studies on our website at
www.covanceclinicaltrials.com/browseourstudies
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Volunteering with Covance is a great way to increase your
earning potential whether you’re a
student, retired or simply fancy trying something di�erent.
There are plenty of studies to choose from. Trials vary from two
day stays to one month residential
and these include weekday and weekend studies, so there’s bound
to be something that suits you.
If you fancy joining leading experts in medical research to
develop groundbreaking treatments for
everyday conditions like asthma, Parkinson’s and psoriasis we’d
love to hear from you.
Covance Clinical Research Unit, Springfield House, Hyde Street,
Leeds, LS2 9LH
0800 591 570
0113 394 5200
[email protected]
www.covanceclinicaltrials.com
facebook.com/covanceleeds
follow us @covanceleeds
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Volunteer today and earn from £100 per day
Call 0800 591 570 or 0113 394 5200 now or find out more at
www.covanceclinicaltrials.com
