Research enables scientists to develop medicines that conquer debilitating diseases and enhance our quality of life. Those who need a heart transplant or kidney dialysis, or who have Alzheimer's disease, diabetes, multiple sclerosis, cancer or AIDS can now access a wide range of therapies, thanks to biomedical research.
Through research, the possibility for enjoying a longer, healthier and more productive life is greater than ever before.
Basic vs. applied research
Biomedical research is the broad area of science that searches for ways to prevent and treat disease in people and animals. There are two general categories of research. “Basic” or fundamental research helps scientists learn more about the relationship of various mechanisms in the body. It investigates physical, chemical and functional life processes. The second category, “applied research,” refers to research that is related to a specific disease or disorder. Both types of research — basic and applied — are vital to medical research.
Research models
Scientists use many research methods (or models) that allow them to isolate and study certain features in a living system. The four most common models include computer simulations, in vitro tests, epidemiological studies, and animal models. Researchers use these models to test medicines that, if successful, will move into human (clinical) studies and eventually be approved for general use.
The research approval process
Before a medicine for high blood pressure or acne can reach the marketplace, rigorous safety tests must be performed. The U.S. Food and Drug Administration (FDA) requires that animal tests are conducted on prescription and over-the-counter drugs before human clinical trials occur. Once adequate information is derived from animal studies, a research institution will file an Investigational New Drug (IND) application with the FDA in order to begin clinical trials.
A drug is tested for safety and efficiency in three trial phases before it is made available to the general population. Once a drug has been through the three phases, a research institution will file a New Drug Application (NDA) with theFDA, which then determines whether a drug is ready forwidespread use.A fourth phase occurs after a drug is approved, and explores its long-term effects. It currently takes about 12 years from initiating laboratory research studies to submitting an NDA for a new medicine to be approved by the FDA.