The development of a new medicine
is often a lengthy and costly
process. Before a new medicine is
licensed for widespread clinical
use, its effects must be thoroughly
assessed in healthy volunteers.
Medicines are first rigorously
tested in the laboratory, sometimes
for many years, before the drug is
finally considered safe to be tested
upon humans.
A clinical trial is the scientific
term used to describe the testing of
a new medicine or medical device to
evaluate whether the drug or device
is effective and safe for people to
use. Other terms often used to
describe clinical trials are drug
studies or drug research.
A phase I clinical trial is the
crucial early stage in a medicines
development when it is first tested
on healthy subjects. The purpose of
a phase I study or trial is to
measure the levels medicines reach
in the body after one or more doses
of a drug. Measurements are taken to
see how quickly medicines are
eliminated from the body and to
record any side effects that may be
caused. Blood and urine samples from
those participating in the study are
used to calculate these
measurements.
Clinical trials
are carried out under the strict
supervision of fully qualified
doctors, nurses and other health
professionals and all trials must
first be approved by an Independent
Ethics Review Committee. The
Independent Ethics Review
Committee’s comprise of both
laypersons and professionals and
their main concern is safeguarding
the interests of the volunteers.
Veeda Clinical Research works in
accordance with ICH Good Clinical
Practice (GCP) which is an
international ethical and scientific
quality standard for the conduct of
trials.
