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CLINICAL RESEARCH - QUESTIONS & ANSWERS
Who pays for clinical trials?
Clinical trials are conducted, or ‘sponsored’,
by a wide range of organisations. They include:
• Pharmaceutical companies, either solely or
jointly with other research institutions such as universities
and hospitals;
• Private research organisations under a grant
from the government’s National Health &
Medical Research Council or from public donations;
• Publicly funded research organisations such
as universities and teaching hospitals.
• Regardless of the type of organisation sponsoring
the clinical trial, the clinical trial must be approved
and monitored under the ethical and good clinical
practice guidelines set down by the Australia government.
What happens if there are side effects from
participating in a clinical trial?
By the time a medicine reaches the clinical trial
stage it has already been extensively tested in laboratories
for likely side effects. However, part of the purpose
of the clinical trials is to see what unexpected side
effects emerge, and how severe or common they are.
So as well as experiencing the benefits of a new medicine,
there may also be side effects for some people.
Your HHMP doctor or study nurse will carefully record
any problems or side effects you have, and these are
relayed to the principal researcher to ensure that
you are kept as safe as possible.
In company sponsored clinical trials, compensation is
available for participants who suffer personal injury
(including death) caused by participation in clinical
trials. Copies of the Guidelines for Compensation for
Injury Resulting from Participation in a Company-Sponsored
Clinical Trials are available from Medicines
Australia.
What happens with the results?
As well as being reviewed by the government authorities
such as the Therapeutic Goods Administration, the
results of the clinical trials may be reported in
the medical press and are made available for doctors.
The publication of results is done so that doctors
can make scientifically valid assessments of the benefits
and risks of a new medicine for their patients.
Although the results of the study may be published,
nothing that identifies individual patients will be
released. All details of a clinical trial participant’s
treatment are kept confidential and patient anonymity
is assured.
In addition, your HHMP doctor will be notified of
the results of the study as soon as they are made
available. Your HHMP doctor should be able to inform
you of the outcomes of the clinical trial. If you
participate in a study, it is recommended that you
keep in touch with your doctor so that you can find
out the results of the study when they become available.
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