What is a Clinical Trial? Clinical trial process and phases
Before a pharmaceutical drug can be approved by the FDA for use in the United States, it must go through several phases of testing, called clinical trials.
During the clinical trial process, the potential drug is tested for safety and effectiveness. Volunteers are followed very closely by the doctor running the trial, called the Principal Investigator. Most clinical trials require regular office visits and more frequent medical tests, such as blood draws, ECGs, or physical exams. In addition, patients are often asked to keep careful record of changes to their health.
After receiving permission from the FDA, the clinical trials begin. Each drug goes through the following phases of testing:
Ninety-percent of drugs that reach Phase III go on to final evaluation by the FDA to seek approval for public use. Though the process takes many years, the end result of new, more effective treatments options makes the effort worthwhile.