What Are Clinical Trials For?

Clinical trials are a product of the Food and Drug Administration of the United States government. The FDA is responsible for regulating and approving all of the drugs that come to market in the US. In order to do that, it has produced an approval course of action that takes up to a decade for many drugs. What does this average for you, the average consumer? It method that if a cure for AIDS were discovered today, it could not be proscribed by your doctor for years.

At first to peek briefly, that seems like a travesty. After all, people are dying of AIDS every day, and thousands or more would die in the US alone in the next year. However, the precautions taken by the FDA are better than the unregulated different that we could be dealing with. The reason is simple safety. What good would a drug that cured AIDS really do us if it turns out that 2 years down the line, it causes enormous congestive heart failure in seventy percent of its takers?

That scenario is exactly what clinical trials are supposed to prevent. They are designed to check two aspects of a drug’s existence: its safety and its efficacy. Safety seems fairly straightforward, but it is much more complicate than it looks at first brush. First, you have to know how the drug interacts chemically with the different cells in the human body. This is the first stage of drug research, where scientists clarify how a particular condition affects the body and come up with a chemical structure that could combat the problem. That is the intended effect of the drug. How well it performs that effect is the efficacy of the drug.

But scientists also have to study how the drug interacts with other drugs in the body. No human exists in a vacuum, and so a drug must both be safe for use, and also not cause unhealthy responses with other medications or already food. This is the first part of the safety testing.

The second part of a clinical trial’s test for safety involves the long term effects of a drug. While scientists can precisely predict how a drug will affect the cells it is targeting, it is much more difficult to gauge how the drug will interact with bodily systems over a long period of time. After it is used, how is it processed by the kidneys or liver? How does a medication for blood pressure affect the clotting ability of a person? How does a cholesterol blocker interfere with your glandular bodily control? These are the types of questions that can only be answered by controlled testing, and that is why clinical trials exist: to make sure that the drugs we take do what they are supposed to, and don’t inadvertently harm us by doing it.

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