Phase 1 - first time into humans
These trials are designed to establish the safety of the treatment, and the approximate dosing range. These studies are performed in healthy volunteers and require extensive monitoring following treatment. Phase 1 trials typically involve 20-60 people and are conducted within a hospital environment.
P3 Research does not undertake any Phase 1 trials.
These trials are designed to show that the treatment works in the 'target' population i.e. people with the disease that the treatment is designed for. Phase 2 studies typically involve 50-200 patients and may involve many tests to look at what effects the treatment has on the body and how the treatment is absorbed, metabolised and eliminated from the body. Usually, a range of doses are tried to look at differences in effect, and any side-effects that are seen. These studies will help the researchers find the best dose and dosing interval that has the desired effect.
These trials usually involve very large numbers of patients (several hundreds or thousands), to identify side-effects that weren't seen in the Phase 2 studies and to find out more information about the proposed dose and dosing interval. These studies may be performed at out-patient clinics and may take several months to complete.
Phase 4 - post-marketing studies
These trials are generally conducted after the product has reached the market. They may involve several hundred or thousands of patients and are designed to see how the product is received by the general public. These studies may identify rare side-effects that were not seen in the smaller pre-marketing studies. These studies may be performed by GPs or other health-care providers.