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Medical researchers are
required to undertake
clinical trials to test all
new drug therapies, devices,
techniques and other
treatments that are intended
to be used to treat humans.
Volunteers, often with
serious diseases, are
recruited to test new
therapies and determine how
well they work. Proposed
treatments involving genetic
technologies are subject to
the same, or higher, level
of scrutiny in clinical
trials as all other new
treatments.
Government regulatory
bodies oversee clinical
trials and consider their
results a central part of
the approval process for all
new treatments. Australia’s
Therapeutic Goods
Administration (TGA) has
national responsibility for
approving and monitoring all
new medical treatments. Its
powers and procedures are
consistent with its
counterparts in other
countries, including the US
Food and Drug Administration
which provides the
international benchmark in
this field.
Clinical trials involving
human subjects are generally
undertaken after a treatment
has been developed and
tested using animal trials.
Up to four phases of
clinical trials can be
undertaken:
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Phase 1:
the proposed treatment
is administered to a
small number of human
subjects to ensure it's
safe, identify side
effects, and determine
safe dosage levels.
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Phase 2:
the treatment is given
to a larger number of
subjects, usually
several hundred, who
suffer from the targeted
illness, to test its
effectiveness and
further evaluate its
safety.
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Phase 3:
up to several thousand
sufferers of the illness
are given the treatment
to confirm its
effectiveness, monitor
side effects, compare it
to existing treatments,
and refine safety
controls.
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Phase 4:
patients who receive the
treatment after its
approval and release are
monitored to provide
ongoing data on
effectiveness, optimal
treatment regimes, and
safety.
The National Health and
Medical Research Council (NHMRC)
has set strict and
comprehensive guidelines for
clinical trials in its
National Statement on
Ethical Conduct in Human
Research.
These include:
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A clinical trial must be
approved by a Human
Research Ethics
Committee (HREC)
attached to the
institution conducting
the trial. Ethics
committees are made up
of professional and
community
representatives.
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Clinical trials must
observe Commonwealth,
State and Territory
laws, NHMRC guidelines,
World Medical
Association guidelines,
the Note for Guidance on
Good Clinical Practice
(as set by the
International Committee
for Harmonisation) and
meet standards set by
the TGA and the
International Standards
Organization.
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They must be designed to
answer specific
questions about a
therapy or procedure
that shows promise of
being at least as good
as existing ones.
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Clinical trials must be
conducted by qualified
people who must be fair
in their selection and
recruitment of
participants.
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Risks to trial
participants must not
outweigh likely
benefits.
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Participants, or their
legally responsible
guardians, must be given
sufficient information
to ensure they can give
their informed consent,
and their privacy must
be protected.
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It is unethical to use
placebos or other means
whereby a control group
of participants do not
receive a treatment that
has been shown to be
effective, or where
there is risk of
significant harm in the
absence of treatment.
Proposed trials
involving control groups
may be considered by the
HREC if there is genuine
uncertainty about the
net clinical benefit of
a treatment.
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Trials may be terminated
if participants
experience unexpected
side effects or if it is
deemed to be in the
public interest.
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If a trial is comparing
treatments and one
proves much better or
worse than the others,
the trial may be
modified or terminated
so that no participants
are disadvantaged.
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Data, records and
biological samples
should be preserved, so
that participants can be
traced if late or
long-term effects
emerge.
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Researchers must make
arrangements for
adequate compensation to
be provided to any
participant injured in a
trial.
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HRECs must be informed
of any possible conflict
of interest facing
researchers involved in
the design and conduct
of a clinical trial. The
HREC must be kept up to
date on the trial as it
progresses, and must be
told about any serious
or unexpected events in
the trial
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