Drug Studies

Drug studies are known as clinical trials. The FDA needs conclusive information that a drug will do what it claims to do, before it is sanctioned for public use. These trials are often long, tedious and often fail. Drug studies are common and studies of every kind are ongoing. Yet drug studies are the most demanding, more imporant, and are the most watched of all clinical trials.

Some are privately supported, while others are government supported. How do they work? They take a step by step -- phase by phase-- approach to test the drug before it is released to the public. Lots of studies are done before humans ever get involved, and this done for their safety.

Step one with human volunteers begins with a study to see how the overall effect of the drug is on healthy humans. Usually twenty, or maybe a hundred, will be participating in the study. Usually, there is pay involved. The investigators will want to know how the drug absorbed, how the body metabolizes it, and how the body eliminates it. In this phase, the side effects are first seen.

The next step or phase is testing the drug on those who have the disease. This is to find out if it does what it claims to do. Over a period of time, sometimes up to two years, and including maybe a hundred or two hundred patients, information on how the drug deals with the disease is sought. Studies are often blind, with one half getting the real drug, and the other half getting a placebo.

Not all drugs started on these trials finish. About one third of those started get past these first two clinical trials. The third stage is more random, yet often still blind, and most likely thousands of patients will be involved. This shows the effectiveness of the drug. After that is known, the drug company then requests approval from the FDA.