| Clinical trials are a product of the Food and Drug | | | | how a particular condition affects the body and come |
| Administration of the United States government. The | | | | up with a chemical structure that could combat the |
| FDA is in charge of regulating and approving all of the | | | | problem. That is the intended effect of the drug. |
| drugs that come to market in the US. In order to do | | | | How well it performs that effect is the efficacy of |
| that, it has created an approval process that takes | | | | the drug. |
| up to a decade for many drugs. What does this | | | | But scientists also have to study how the drug |
| mean for you, the average consumer? It means that | | | | interacts with other drugs in the body. No human |
| if a cure for AIDS were discovered today, it could | | | | exists in a vacuum, and so a drug must both be safe |
| not be proscribed by your doctor for years. | | | | for use, and also not cause harmful reactions with |
| At first glance, that seems like a travesty. After all, | | | | other medications or even food. This is the first part |
| people are dying of AIDS every day, and thousands | | | | of the safety testing. |
| or more would die in the US alone in the next year. | | | | The second part of a clinical trial's test for safety |
| However, the precautions taken by the FDA are | | | | involves the long term effects of a drug. While |
| better than the unregulated alternative that we could | | | | scientists can accurately predict how a drug will |
| be dealing with. The reason is simple safety. What | | | | affect the cells it is targeting, it is much more difficult |
| good would a drug that cured AIDS really do us if it | | | | to gauge how the drug will interact with bodily |
| turns out that 2 years down the line, it causes | | | | systems over a long period of time. After it is used, |
| massive congestive heart failure in seventy percent | | | | how is it processed by the kidneys or liver? How |
| of its takers? | | | | does a medication for blood pressure affect the |
| That scenario is exactly what clinical trials are | | | | clotting ability of a person? How does a cholesterol |
| supposed to prevent. They are designed to check | | | | blocker interfere with your glandular bodily control? |
| two aspects of a drug's existence: its safety and its | | | | These are the types of questions that can only be |
| efficacy. Safety seems fairly straightforward, but it is | | | | answered through controlled testing, and that is why |
| much more complex than it looks at first brush. First, | | | | clinical trials exist: to make sure that the drugs we |
| you have to know how the drug interacts chemically | | | | take do what they are supposed to, and don't |
| with the different cells in the human body. This is the | | | | inadvertently harm us by doing it. |
| first stage of drug research, where scientists identify | | | | |