A Guide to Clinical Drug Research

The Food and Drug Administration evaluates new drugs before allowing them to hit the market through the Center for Drug Evaluation and Research, or CDER. An important part of the evaluation process is clinical drug research and clinical trials.

Function

• Before selling a drug, a company must test it and the FDA reviews the testing results and the drug. First, a drug must go through laboratory and animal testing. Then human clinical trials are performed.

Features

• Clinical testing takes places in three phases, each involving an increasing number of human test subjects. Phase I contains 20 to 100 participants, Phase II involves up to several hundred test subjects, while Phase III research is conducted on several hundred to thousands of human participants.

Time Frame

• Phase I testing requires six to nine months, Phase II often takes place over several months up to three years while Phase III takes about one to four years of testing.

Considerations

• Ethical and legal codes that govern medical practice are in place with clinical trials to ensure a patient's safety. A clinical trial team will typically consist of physicians, nurses, other health care professionals and social workers.