Why Are Clinical Trials Conducted?
Clinical trials are conducted to test the effectiveness of new proposed drugs and devices in the treatment of specific conditions and diseases. In order to be approved by the Food and Drug Administration, every proposed drug in development has to go through a process of testing commonly referred to as phases.
Phase I trials involve testing a new drug or treatment on small populations (typically 20 to 80 healthy participants and/or patients). The researchers evaluate the experimental drug’s potency, metabolism, and potential side effects.
In Phase II trials, the drug is further tested for safety and efficacy in a slightly larger population of patients (100 to 300) who are afflicted with the disease for which the drug was developed.
Phase III trials require the drug be given to groups of roughly 1,000 to 3,000 afflicted patients. These studies test the drug in comparison with the standard therapy currently in use, verify that its benefits outweigh the risks, and provide information for the package insert and physician labeling.
Once the drug has been approved by the FDA, Phase IV trials are conducted to compare it to a competitor, identify optimal use, and further study any adverse reactions.
This process ensures that the drug is effective and ready to be marketed to the general public. Clinical trials are essential in the progression of modern medicine.