What Are The General Phases Of Clinical Research?
Clinical trials are an important part of developing drugs and medical devices for use by the public. The role of research and trials is to ensure that the final product is not only safe for the people who will use it, but that they will perform the function that they are designed for. These trials are usually organized in four phases.
Phase 1 of a clinical research involves testing the treatment on a small group of people. These are usually volunteers, and the role of phase 1 research is to establish the efficacy, safety, ideal dosage ranges and the side effects of the treatments. If satisfactory, the treatment is moved to phase 2 which involves administering the drug to a larger group of people to get more information about its efficacy and safety.
If the treatment has satisfactory results in phase 2, phase 3 of the trial is commenced. This involves administration of the treatment to large groups of people, but with the intention of monitoring its effectiveness as well as comparing it commonly used treatments. For instance, if a new antibiotic is developed, phase 3 trials would involve comparing its effectiveness with other available antibiotics in its class.
Once all these phases are completed successfully, the treatment is now submitted for approval by the FDA and then made available to the general public. At this point, phase 4 of the research is commenced. This is a very long term phase which involves monitoring drug use in the population, and gathering information about long term use of the treatment.