If you have ever wondered how a drug (or device) gets on the market and becomes available in the United States, clicking our website was the right choice. For the safety of the people in the USA, the FDA , Food and Drug Administration, is the agency in place that reviews for approval all new drugs and devices.
The FDA approval process is highly regulated. Our focus is the component of the process called clinical research trials. The trials in humans are done in 4 phases.
Phase I is referred to as the Safety and Dosage phase. This is the first time it will be used in/on humans. These trials are generally quite small in number of participants and are done with healthy human subjects.
Phase II is the Efficacy and Side Effects phase. This is where we see if the drug or device actually does what it is supposed to do and what the side effects may be. To participate in this phase you generally must have the disease/condition that the test/trial is about.
Phase III testing is for Efficacy and Monitoring of Adverse Reactions. Much larger groups of people are involved in this phase. Still looking at the efficacy (does it do what it is supposed to) and what other effects may be associated with it’s use. Again, looking for participants who have the disease/condition associated with the specific trial.
At this point the FDA generally determines weather it will grant approval or not. If no approval is granted, it is either back to the drawing board or to the chopping block for the Investigational Drug or Investigational Device… If approval is granted, we move on to the last phase of clinical research trials.
Phase IV is referred to as the “post-approval” safety and efficacy” portion of the trial process. These trials may involve several thousand volunteers all of whom will have the indicated condition/disease.
We hope you have a better understanding of the phases of clinical research trials. As always, feel free to CONTACT US to learn more and to become a participant in this exciting part of the drug and device development process.