What Is Clinical Research?
Clinical research is the process that tests new products such as drugs, devices and biologics, in humans. The goal is to obtain approval by
the Food and Drug Administration (FDA) and make the product available to everyone, incorporating it
into medical “standards of care.”
What does clinical research do? It leads to new and better medical care by allowing clinical researchers to evaluate what works and what doesn’t through a methodical and scientific approach.
When research scientists make a promising discovery in the lab, they first test it carefully in animals. When confident of its safety, they take it to the next step—learning how the new product will perform in people.
Medical Experts Control Studies
Clinical research studies are conducted by professionals who provide medical care for study volunteers while gathering data about the product being tested. The person in charge of the study often is a medical doctor who is referred to as the principal investigator. The study coordinator works closely with the principal investigator and study volunteers. These professionals follow strict rules, and both federal and state governments are involved in making sure the studies are done safely. In addition, a completely independent group called an Institutional Review Board (IRB) approves the study and protects the rights of study volunteers.
Volunteers Make Research Possible
People volunteer to participate in clinical research studies for a number of reasons. Some hope to find a new treatment or cure for a disease they have. Others want access to new drugs and free medical care that the studies provide. And many volunteer to help advance medical care and benefit society.
Here are a few more details about clinical research studies:
Drug research progresses in specific steps, called phases.
Each phase of a clinical research study has a different purpose and helps researchers answer different questions. Clinical research studies follow an approved plan.
Every study follows a detailed plan called a protocol.
The protocol indicates what research questions the study will answer and how the study volunteers will be involved. Every detail must be outlined and approved before the study can begin.
If you are interested in participating in a clinical research study, please click here to see our currently enrolling studies.