Phase III clinical trial highlights
• The majority of phase III clinical trials involve a high number of patients, usually several hundred.
• These studies are frequently conducted in multiple locations across the country (or even around the world) at the same time.
• Phase III clinical trials are more likely to be available in community hospitals and doctor’s offices, and they endure longer than phase I and II studies.
• Placebos may be employed in some phase III studies, but they are never utilized alone if a medication that works is available. A patient who is randomly allocated to the placebo for part of the study may be offered the usual treatment at some point. Patients in phase III clinical trials, like those in other trials, are continuously monitored for side effects, and therapy is halted if they are too difficult to control.
An application seeking FDA approval: New medication application (NDA)
In the United States, a new drug application (NDA) is submitted to the Food and Drug Administration (FDA) for approval when phase III clinical studies (or sometimes phase II trials) prove that a new drug is more effective or safer than the present treatment. The FDA examines clinical trial outcomes as well as other pertinent information.
The FDA chooses whether to approve the medication for use in patients with the ailment for which the drug was evaluated based on the review. If the new treatment is approved, it often becomes the standard of care, and other medications may be tested against it before they are approved.
If the FDA believes that more evidence is required to demonstrate that the new treatment’s benefits outweigh its hazards, it may request additional information or even demand additional research.
