Clinical research is the process a new drug must go through before your physician can prescribe it for you. The whole process usually takes 12-18 years.
When a drug company discovers a new drug in their laboratory, they test it on animals. This testing shows if the drug is safe and if it will help combat any disease. Once the animal testing is complete, the drug company sends their findings to the Food and Drug Administration (FDA). The new drug is classified as an Investigational New Drug (IND).
The FDA studies the drug company’s findings to determine if the new drug is safe for humans. If the FDA decides that the drug is safe, they allow the drug company to begin a human clinical trial.
Clinical trials on humans are separated into 4 parts or phases.
Phase 1 trials mainly test for safety and studies how the drug works in humans. It usually only has a few people in it. These patients are watched very closely and often have to stay overnight in a hospital.
Phase 2 trials study the value of the drug in combating the disease. It has more study patients that Phase 1, but still has a small number (50-500) of patients.
Phase 3 trials study the drug’s effect on different types of patients. They are looking to see if the drug works differently in
¨ Men and women
¨ Older and younger patients
¨ Different races
After Phase 3 is complete, the drug company goes back to the FDA to ask permission to sell the drug for the specific disease.
Phase 4 trials are usually conducted after the FDA approves the drug for use by the public. Phase 4 studies are looking for more information about side effects and possible new uses for the drug. The drug company must report on the drug to the FDA every 2 years after approval.