Anyone know what is meant by phase 3 trial of a drug?

Question

what happens in a phase 3 trial???

corrected from other question.

Answer 1

Phase 3 Trial is basically a larger scale Phase 2 trial. Phase 2 Trials are used in a small percentage of the population to see the efficacy of a drug. It is usually very small scale, maybe a couple hundred participants. A Phase 3 Trial is for determining the safety AND efficacy of a drug in a larger population (any unwarranted side effects?). It usually includes several thousand people.

Answer 2

Phase III studies are large double-blind randomized controlled trials on large patient groups (1000-3000 or more) and are aimed at being the definitive assessment of the efficacy of the new therapy, especially in comparison with currently available alternatives. Phase III trials are the most expensive, time-consuming and difficult trials to design and run; especially in therapies for chronic conditions. Once a drug has proven satisfactory over Phase III trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of 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 various regulatory authorities in different countries, such as the Therapeutic Goods Administration (TGA) in Australia, the European Medicines Agency (EMEA) or the Food and Drug Administration (FDA) in the United States for marketing approval.

Answer 3

the focus test group is widened to several hundred while animal testing is continued, and origional patients are kept in trial to test for long term exposure risk

fda.gov will have all the details. just do a general search