The FDA has a tough trial schedule for drug testing.
For a drug to be approved for general consumption, it must go through several testing phases by the Food and Drug Administration (FDA). There are three phases before the drug goes on the market and a fourth phase after the drug has been introduced to the public. According to the U.S. National Institutes of Health (NIH), there are currently over 90,000 trials going on in more than 150 countries.
Before Human Testing
Before a drug can enter human testing phase, it must first be tested in animals. Researchers have created what are known as animal models, animals created to show symptoms of specific diseases. Possible drug therapy is administered to these animals first to test for efficacy of the drug as well as side effects.
Phase I
Phase I trials are primarily used as a measure of safety. Instead of testing on people with an illness, Phase I trials use a small number of healthy volunteers, somewhere between 10 and 20 people, to test for dangerous side effects as well as how the drug is processed by the body. After several months, if no danger is identified, the drug can pass into the next phase.
Phase II
Phase II trials are the beginning of efficacy trials. The trial group expands to several hundred people, most if not all of whom have the disease the drug is intended to treat. The group is split into two halves, with half the people receiving the drug in the trial, and the other half receiving a placebo, an identical-looking treatment that contains no medication. The point of this test is to measure whether the drug is effective. If those receiving the drug have no more improvement compared to those on the placebo, the drug will not pass to the next phase.
This is the phase where many drugs fail out of testing. Only about one third continue on to Phase III.
Phase III
Phase III launches a large-scale version of Phase II. Thousands of people are selected, with half receiving the placebo. The purpose of expanding the group to this level is to test the efficacy of the drug across gender, age and disease condition amongst a high number of test subjects. It gives drug companies a better understanding of how well the drug will work in the entire population. This phase can take several years to complete, but if a drug has already made it this far, over 90 percent are approved.
Phase IV
Once a drug has been approved, it still undergoes monitoring during Phase IV. This phase, also known as post marketing surveillance trials, is used to watch for long-term side effects, impact on a patient's lifestyle and comparative effectiveness to other drugs on the market. Even at this phase, which can last for several years, the drug can still be pulled from production.
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