What is a Clinical Research Trial?

A clinical trial is also referred to as a clinical research study. It is a scientific study that evaluates the safety and effectiveness of investigational medical treatments, drugs, or devices in people. A clinical trial may show that the investigational treatment is better than, as good as, or no better than the standard treatment. Or it may confirm the discovery of a successful treatment for a disease that previously had no treatment options.

Pharmaceutical companies or other health organizations are typically the sponsors of these clinical trials. They are responsible for funding and for designing its protocol. The protocol is the detailed guideline for conducting the study. Only trained doctors, nurses, and other medical staff conduct the study itself. Patients in clinical trials are volunteers who qualify for the study and agree to take part.

Clinical trials are the only way that testing can be done. The Food and Drug Administration (FDA) requires the satisfactory completion of clinical trials before it will approve a new treatment as safe and effective for public use. Clinical trials are the link between research and the development of new therapies.

All research is overseen by a Institutional Review Board (IRB). This review board is a group of individuals who are responsible for reviewing the study. During this review the IRB is making sure the participant for the studies rights and welfare are protected.  The IRB members that review these study designs are both male and female. They are members of the scientific community, nonscientists, doctors, nurses, pharmacists, and community members. IRB approval must be obtained before any study may begin. The IRB evaluates the risks to participants and makes sure that any potential risks are minimized. The IRB reviews the informed consent and make sure that it is complete in describing the study including the risks and the benefits and they assure the study is conducted in an ethical manner.  Once they believe all the conditions are met they give their  approval  and then the study may begin. Periodically they then review the approved study to assure the rights and welfare are appropriately protected.