Thursday, September 2, 2010

A Study in Studies

Clinical trials.

What are they?

This question has plagued my mind for quite some time. After all, the phrase surfaces often in the news and in virtually every magazine ever published.

But what purpose do they really serve?

After reading through the summary of a study on rheumatoid arthritis, I think some of this confusion has been cleared up. A clinical trial is nothing but a research study in human beings. It's typically done to study various reactions to a medicine that is still in the trial stage.

The particular example I examined was a double-blind, placebo attempt to validate the use of a drug aimed to treat rheumatoid arthritis. What exactly do those terms mean?

To quote from

DOUBLE-BLIND STUDY: A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study.

PLACEBO: A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness.

So a placebo is basically: nothing. It's useless. It's a waste of time. If you're the person receiving it, you can't expect anything to happen.

But if you're a placebo recipient in a double-blind study, you wouldn't know it. That's what a double-blind study is: neither the participants nor the overseers really know who is the control group and who is actually receiving a functional drug.

Now, I've mentioned something new: the control group. The control group is nothing but the placebo group. Everything else between the two groups is exactly the same. The only difference between the control group and the group actually receiving the drug is that one group actually receives the drug.

So let's set up a hypothetical situation which is an attempt to see if a drug that is hailed as fighting cancer would work. There would be two arms (groups--the control and the experimental). The control group would receive nothing but the placebo--so we could measure the results of what would happen without the drug. The experimental, on the other hand, would receive varying amounts of the drug over an extended period of time.

Once this time had expired, we could collect results. Was there a notable increase in the condition of the experimental group? If so, then perhaps the drug is notable and should be studied further. But on the other hand, if the condition of the experimental group degrades compared to the placebo group, then there are probably some adverse effects from the drug, which would need to be scrapped.

So I hope that I have cleared up some of my own confusion when it comes to what a clinical trial is. It's nothing but an attempt to carry out an experiment in humans. This is typically done to study the effects certain medicines can have on their targets. There are different setups possible, including the double-blind, in which neither the participants nor the personnel really know who receives the real drug or not.

Does anyone else not want to be in a clinical trial anytime soon?

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