Clinical research uses human volunteers to answer specific health questions. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. These treatments are being evaluated by the Food and Drug Administration (FDA) for approval to be marketed to the general population.
According to the FDA and Biotechnology Industry Organization:
There are more than 300 biotech drug products and vaccines currently in clinical trials targeting more than 200 diseases, including various cancers, Alzheimer's disease, heart disease, diabetes, multiple sclerosis, AIDS, and arthritis.
Biotechnology is responsible for hundreds of medical diagnostic tests that keep the blood supply safe from the AIDS virus and detect other conditions early enough to be successfully treated.
The biotechnology industry has mushroomed since 1992, with US health-care biotech revenues increasing from $8 billion in 1992 to $39 billion in 2003.
Biotechnology is one of the most research-intensive industries in the world. The U.S. biotech industry spent $17.9 billion on research and development in 2003.
In the year 2005, 80 drugs were approved as a result of the conduct of clinical research trials. 87 drugs have been fast-tracked by the FDA in 2007. The fast-track program facilitates the development and expedites the FDA's review of new drugs and biologics that demonstrate the potential to address unmet medical needs for serious or life-threatening conditions.