Phase III

Phase III trials involve hundreds of patients at 20-50 clinic sites and always have a randomization process.  Randomization is another method used to prevent bias in research.  Randomization assigns treatment arms by a computer or table of random numbers, similar to the chance effect of a “flip of the coin.”   Randomization assures that treatment arms are distributed equally (randomly) between patients, and that patient groups are as similar as possible.  Randomization is the best way to prove effectiveness by revealing if any true statistical significance occurs due to the study drug.  Phase III trials are designed to test a study drug vrs standard of care drug to evaluate superiority that ultimately may improve upon standard of care.  The usual design is Arm A (study drug) versus Arm B (standard of care).  Newer trials may use up to 4 arms to test different combinations of study drugs and other chemotherapeutic agents versus standard of care.  Phase III trials account for the largest percentage of patients on trials, are the most expensive to sponsor, and may take 3-5 years to complete.