Clinical trials assess the safety and effectiveness
of drugs. Some trials test entirely
new drugs.
Others evaluate whether older drugs
should
have their recommended dosages adjusted,
or if they can be used to fight different
diseases.
- Phase I trials assess whether a given drug
can be consumed safely by humans.
- Phase II trials determine if a drug is effective
for its stated purpose.
- Phase III trials take drugs that show promising
results in phase II, and administer
them
to larger numbers of people to confirm
the
results.
- By participating in a trial, a volunteer
assumes risks. The drug may be harmful
or
fatal. Damaging effects might not
manifest
themselves until years later.
- In phase II and III trials, volunteers normally
do not know whether they are really
getting
the experimental drug, or a placebo
instead.
Those who receive the placebo may
lose valuable
time in the fight against their condition.
- A treatment that is safe and effective in
adults may be harmful to children,
at least
in the adult dose. Determining the
appropriate
dosage for children requires the
participation
of youngsters in the trials, at potential
risks to themselves.
In cancer treatment trials, children
play
an overwhelming role. Approximately
75% of
children with cancer participate in
a trial
at some point, versus 2-5% of adult
cancer
patients. The gravity of the disease
and
the need for timely action motivates
parents
and guardians to seek new therapies
for their
kids.
If you or your child is not responding to
conventional treatment and you wish to consider
enrolling in a trial, approximately 41,000
are currently underway. See www.centerwatch.com
or www.clinicaltrials.gov, which also can
be accessed through www.nih.gov. The NIH
(National Institutes of Health) is a federal
agency that sponsors over $20 billion of
research annually.
When considering entering you or your
child
in a trial, seek out second opinions
and
be sure to ask the key questions, such
as:
- what are the risks
- what all the treatment alternatives are
- how success is defined
- whether you can be assured that your child
will get the test drug rather than a placebo
- who will pay for the trial
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