Phase III

Phase III trials involve a much larger group, between several hundred to several thousand patients, to help determine if the new drug can be considered both safe and effective under mid to long-term assessment.

The goals of a Phase III trial are:

• to confirm the safety and efficacy of results obtained during Phase II trials,
• to compare the new drug to other compounds either with a placebo (an inactive version of the new drug) or other standard therapies, to see if the new drug out-performs its competitors.

Phase III trials may also be used to assess the efficacy and safety of the new drug when given in combination with other approved therapies.