Phase III Clinical Trials

Phase III trials are one phase of a clinical trial. During this phase, new treatments are compared withthe currently available standard treatment. These trials provide the pharmaceutical companies and the FDAwith a more thorough understanding of the safety, efficacy and correct dosage of a drug.Only 1/3 of drugs ever make it to Phase III clinical trials. Drugs that progress to PhaseIII are always tested for effectiveness in the treatment or cure of a specific condition. Phase III trials are considered to be more complicated than other phases as these trials are the longest and largest out of all the other studies that are conducted.

Depending on the study design,Phase III trials usually involve anywhere from 300 to 3,000 participants with similar demographic traits. The trials are randomized to make sure that the people in all trial arms are alike. A computer program is used to randomly assign people to the trial arms.This helps scientists to understand that the results of the trials are due to the treatment and not because of differences between the groups. These studies may take place in multiple centers, in several countries or around the world at the same time. Phase III trials cancontinue for a duration of two to five years.

Key information about Phase III clinical trials:

• These trials involve a large number of participants.
• Studies are often conducted in many places across the country or around the world at the same time.
• They are the longest and largest out of all the other studies that are conducted.
• Trials are randomized to make sure that the people in all trial arms are alike.

International Research Services, Inc. (IRSI) is committed to providing personalized and professional clinical trial services to cosmetic and pharmaceutical enterprises of any scale, with the utmost attention paid to subject safety, regulatory compliance, quality of results and superb customer service.To arrange for a visit or to find out more about our capabilities, call 914-937-9483 or 1-800-548-0158 or email sschwartz@irsi.org or ffriscia@irsi.org