Study Participants
Why Research is Important:
Pharmaceutical sponsored drug research leads to new therapies that save and improve millions of lives. The Food and Drug Administration (FDA) holds pharmaceutical companies to the highest standards before a drug is approved for use. Every year, thousands of new drugs are tested for efficacy, side-effects, and safety. As a study volunteer, you will be instrumental in making investigational drugs available for future use.
At Remington-Davis, we participate mainly in “Phase II” and “Phase III” pharmaceutical studies.
Phase II
Once initial safety of an investigational drug has been confirmed on human subjects through a Phase I study, Phase II trials are performed on a large group ranging from 20 to about 300 subjects. Phase II clinical trials are designed to assess whether the drug does what it is supposed to do.
Phase II studies are sometimes divided into Phase IIA and Phase IIB. Phase IIA is specifically designed to assess dosing requirements, whereas Phase IIB is specifically designed to study efficacy.
Phase III
Phase III studies are controlled trials on large patient groups and are aimed at being the definitive assessment of the efficacy of the new therapy. Phase III trials are the most expensive, time-consuming, and difficult trials to design and run; especially in therapies for chronic conditions. Once a drug has proven efficacy and safety through at least two Phase III trials, the results are combined and submitted to the Food and Drug Administration (FDA) in the United States for marketing approval.
Other reasons for performing trials at this stage include attempts at "label expansion” to prove additional efficacy for uses beyond the original use for which the drug was designed, to obtain additional safety data, or to support marketing claims.