Posts Tagged ‘ Drug Studies ’

What You Should Know About Drug Studies

November 19th, 2009. By Kristine B

In light of the recent release of the results from the ARBITER 6-HALTS trial regarding Zetia and Niaspan, there may be questions about what drug studies are and why they are important. This week, Pleading Ignorance examines drug studies: what they do, what they don’t do and what you should know about them.

Drug Studies: What They Do (Timing is Everything)

The names of the drug studies are impressive, aren’t they? Names like ARIBITER 6-HALTS, ENHANCE, RECORD and so on. The fancy thing is that all the letters in the names mean something (an acronym!)—but no one ever remembers what the heck they mean, save of course the folks conducting the test. So the catchy name is fine for the rest of us. (By the way, ARBITER 6 HALTS stands for “Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6–HDL and LDL Treatment Strategies“—say that fast 6 times). Once you’re beyond the name though, it’s important to know at what point in time the study is being done—after all, the studies are designed to show something. The timing in which the drug is tested will clue you in to what information the researchers are looking for.

Drug studies that are done before the drug is approved by the FDA (known as clinical trials), are done to prove…

• that a new drug is at least as effective as an older drug
• that the new drug is more effective than just standard therapy alone, or
• that the benefits of the new drug outweigh the risks (see, they’re watching out for you!)

If the studies are done after the drug is approved, they may be done to… Read the rest of this entry »

Tags: Drug Studies, Drugs, FDA, Pleading Ignorance
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