“Phase III trials are conducted to confirm and expand on the safety and effectiveness results from Phase I and II trials, to compare the drug to the standard therapies for the disease or condition being studied, and to evaluate the overall risks and benefits of the drug.
Phase III studies are commonly randomized multicenter controlled trials on large patient populations (300–3,000 or more depending on the disease/medical condition studied) and are meant to be the definitive measure of how successful the medication is relative to the existing ‘gold standard’ treatment.
Phase III aim is to determine how the new medication performs for the same condition relative to existing drugs.
Before continuing with the experiment, researchers need to show that the drug is at least as safe and successful as the treatment options that exist.
Because of their size and relatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions.
Once a drug has proved acceptable after Phase III trials, the trial results are generally combined into a large document containing a comprehensive description of the methods and results of the human and animal studies, manufacturing procedures, formulation details, and shelf life.
This collection of information makes up the “regulatory submission” that is provided for review to the suitable regulatory authoritiesin different countries.
Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with the proper recommendations and guidelines through a New Drug Application (NDA) containing all the manufacturing, preclinical, and clinical data.
In case of any side effects being reported anywhere, the drugs need to be recalled without any delay from the market.”
