What is a Clinical Study?
Clinical Trials are carefully regulated studies sponsored by pharmaceutical and bio-technological companies and are made possible by people like you. Qualified physicians and other research professionals supervise clinical trials that are approved by the U.S. government’s FDA as well as Institutional Review Boards. Clinical testing of a new drug is a step-by-step process, done in phases, that ensures you receive careful medical attention.
Phases of Drug Testing:
Once the FDA has granted a New Drug Approval (NDA) clinical trial testing of experimental drugs is normally done in three phases…
Phase I
Phase I trials typically involve healthy volunteers and a small study group. The purpose in this phase of the study is to answer whether the drug inhibits or amplifies the effects of the other medications that might be in taken at the same time.
Phase II
Phase II trials evaluate whether the drug shows favorable effects in treating an illness and seek to determine the proper dose. The study group may be a little larger than the phase I, and evaluation of safety continues.
Phase III
Phase III trials, which is what we specialize in, include the largest study group and this trial phase is designed to provide substantial evidence of efficacy and safety required before the investigational drug is allowed on the market.