Clinical trials evaluate the safety and efficacy of medications and medical devices.
Trials are conducted in five phases.
Pre-clinical (Phase 0)
Non-clinical studies involving laboratory studies and trials on animal populations
Southlake does not participate in pre-clinical trials.
First stage of testing in humans.
Because of potential risks, only a few volunteer subjects are involved and are closely monitored, usually on an in-patient basis.
Subjects are normally healthy, but Phase I trials are sometimes open to terminally ill patients who have not had any success with known treatments.
Southlake does not participate in Phase I trials.
Larger trials (20 – 300 subjects) to assess the efficacy and safety of the treatment.
Phase II trials are designed to determine if the treatment provides any benefit to people with a particular health issue.
Southlake occasionally participates in Phase II trials.
Randomized control trial where treatment is tested blindly against placebo or other treatment on large patient groups (300 – 3,000+).
Phase III trials aim to be the definitive assessment of a new therapy in comparison to the best current (gold standard) treatment available.
The trials involve tens or hundreds of researchers around the world and individuals of different ethnic backgrounds with the same illness.
Phase III trials are also done to proof additional value for medications beyond their original uses (label expansion).
Southlake commonly participates in Phase III trials.
Studies that occur after the medication, device, or therapy is in use.
Phase IV trials may be designed to collect long-term data on side effects or to demonstrate that a treatment is better than others.
Southlake participates in some Phase IV trials.