Clinical Trial Phases

Purpose

The primary purposes of a Phase III trial are to: 

• Confirm the effectiveness of a drug or treatment
• Test the safety of the drug or treatment
• Determine the most effective dosage levels.

Phase III studies look for a treatment that will provide a longer life expectancy, better quality of life, fewer side effects, and/or a lowered chance of the condition returning.

Number of Participants

This larger trial group may include 300-5,000 people or more.

What Happens

Phase III compares standard (proven) drugs or treatments or placebos (no treatment) with the drugs or treatments that appeared to be effective in the Phase II studies. The people who participate are divided into those receiving the standard treatment or placebo, and those receiving the experimental treatment. The responses of the groups are then compared.

If during the trial it is determined that one treatment is superior to another, the trial may be stopped. If that is the case, all participants are given the more effective treatment.

Duration

Phase III trials may range in length from 1-4 years. Approximately 25-30% of drugs and treatments will clear this phase. According to the FDA, about 20% of drugs and treatments that are tested in people will ultimately be approved for marketing.

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