What does the clinical
trials process involve?
All new drugs must complete a series of tests before they can be
prescribed by doctors, or sold in pharmacies and chemists' shops.
The work undertaken by Quotient Clinical, is part of the testing
process. Before any clinical trial can take place, the new drug
undergoes extensive pre-clinical or laboratory tests. As a result,
a Phase I clinical trial will not be started unless experts believe
that it is safe to proceed to clinical trials.
Phase I studies are usually conducted in a small number of
healthy volunteers (someone who does not have any medical
conditions and is deemed therefore to be healthy). In the majority
of Phase I studies, volunteers are given a new medicine. The
purpose of this is to:
- See how long it takes for the body to absorb, distribute,
metabolise (how the body breaks down) and excrete (how the body
gets rid of) the study drug.
- See how the medicine reacts, either when a volunteer is fasted,
or given food, and also to see how it reacts with other
medication.
- Determine the optimum dose level without any unwanted side
effects.
As part of the trial procedures, you will be monitored on a
regular basis. This will be done by taking blood and urine samples,
and by blood pressure, temperature and ECG (electrical heart
tracing) measurements. Our prime concern is your safety and well
being and, as such, we do insist that you adhere to all trial
instructions. The trials are supervised at all times by fully-
trained doctors and nurses.
Each trial requires a different group of volunteers. Factors that
will be taken into account when assessing a volunteer's suitability
for a specific trial may include: age, sex, height, weight and
smoking status.
Full information regarding each trial is made available to
volunteers - together with an Informed Consent
form document - for discussion, before they commit themselves.
Both the information, and the document, are reviewed and approved
by an Ethics Committee. This is a group of independent advisors
which includes consultant physicians and surgeons, general
practitioners, lay persons and nurses.
In recognition of the value of your time, we pay a participation
fee on completion of all trials. The majority of our studies have a
residential element, which means that you must be available to stay
in the clinic for a specified time, and attend any outpatient
visits which may be required.
