Wednesday, May 11, 2005

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In addition, just because something is undergoing a clinical trial
doesn't mean it works or FDA considers it to be a proven therapy,
says Donald Pohl, of FDA's Office of AIDS and Special Health
Issues. "You can't jump to that conclusion," he says. A trial can fail to
prove that the product is effective, he explains. And that's not just true
for alternative products. Even when the major drug companies
sponsor clinical trials for mainstream products, only a small fraction
are proven safe and effective.

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To FDA, it doesn't matter whether the product or treatment is labeled
alternative or falls under the auspices of mainstream American medical
practice. (Mainstream American medicine essentially includes the
practices and products the majority of medical doctors in this country
follow and use.) It must meet the agency's safety and effectiveness
criteria before being allowed on the market.

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In a clinical trial, results observed in patients getting the treatment are
compared with the results in similar patients receiving a different
treatment or placebo (inactive) treatment. Preferably, neither patients
nor researchers know who is receiving the therapy under study.

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Clinical Trials
Before gaining Food and Drug Administration marketing approval,
new drugs, biologics, and medical devices must be proven safe and
effective by controlled clinical trials.