A clinical research trial is a carefully planned research study which is designed to evaluate new types of drugs treatments. Such treatments must undergo years of research and testing on animals (referred to as the "pre-clinical phase") in order to obtain preliminary results on how those treatments may effect the overall body process. If the treatments look promising and are safe, they continue on to clinical research trials (phase I) and are carefully studied in healthy volunteers.
Each study is designed to learn about the effects of drug treatments in a normal volunteer and patient population.
Each time a clinical trial is conducted more and more data are collected about the treatment. Data collected include information on safety, whether the new medication is more effective than existing treatments, and potential side effects.
Clinical Research Trials are important to help find new and better treatments. Carefully controlled and conducted clinical research trials are the only way to find treatments in patients. There are different types of trials and they are generally conducted in four phases.
Phase I
Initial trials are the first stage of testing in humans subjects. Such trials are generally small size studies, which can consist of anywhere from 20 to 80 volunteers. In phase I the study attempts to determine how the body processes the drugs and how the drugs work with the body. Such trials are primary conducted using healthy participants.
Phase II
At this phase the study expands to a larger group of patient volunteers and the clinical research studies are conducted in order to evaluate the effectiveness of the drug or treatment for particular indications in patients with the target disease. If the phase II studies show the developmental program generally continues into phase III.
Phase III
In Phase III the clinical research studies are usually much larger than those in Phase I or II sometimes involving thousands of patients in order to confirm the safety and the effectiveness of the treatment and so as to compare it to other common drugs.
Phase IV
Phase IV consists of post-marketing studies in order to provide all information pertaining to the drug's risk, benefits and optimal use.
