Clinical Drug Trials: Risks and Opportunities

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Clinical Drug Trials: Risks and Opportunities

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.

a.. Phase I trials assess whether a given drug can be consumed safely by

humans.

b.. Phase II trials determine if a drug is effective for its stated

purpose.

c.. Phase III trials take drugs that show promising results in phase II,

and administer them to larger numbers of people to confirm the results.

d.. 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.

e.. 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.

f.. 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 http://www.centerwatch.com or http://www.clinicaltrials.gov, which

also can be accessed through http://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:

a.. what are the risks

b.. what all the treatment alternatives are

c.. how success is defined

d.. whether you can be assured that your child will get the test drug

rather than a placebo

e.. who will pay for the trial