Phase III Trials

Also known as “pivotal trials“, Phase III trials are rigorously-defined clinical studies intended to establish the efficacy of a drug to an acceptable level of statistical certainty. Phase III trials may involve as few as 100 or as many as 10,000 patients depending on the drug category, usually involve several sub-studies known as “arms” and almost always involve “blinded” control groups who receive a “placebo”. The results are rigorously reviewed by regulators, and several Phase III trials may be necessary to gain regulatory approval.