Clinical Trials
Categories: Company Management, Regulations
In the old days, traveling salesmen sold snake-oil cures and revitalizing tonics (mostly alcohol and cocaine concoctions) from the backs of wagons. Except for some particularly sketchy supplements, these practices have largely become extinct. Instead, modern pharmaceutical companies have to go through a long, expensive process scientifically proving that their medicines are safe and, uh...do what they claim they do.
The tests that prove these facts are called clinical trials.
Typically, the trials are broken into three phases, named (somewhat boringly): Phase I, Phase II, and Phase III.
Phase I trials only involve a few patients. If everything checks out with the drug being tested, it graduates to the next stage. The patient pools get bigger at each stage, until the companies have gathered enough data to apply for approval from the FDA (the U.S organization in charge of overseeing the drug industry) or the equivalent regulator in other countries.
In conducting the studies, companies compare the effects of their trial medicines with placebos to make sure that the drug actually improves health the way it should, and doesn't hurt the people taking it.