University research hospitals and some health-oriented private companies rely on clinical research to gain critical knowledge about specific treatments or behaviors, which in turn, can make the biggest positive impact in many people’s lives.
Before any new experimental treatment can gain approval from the Food and Drug Administration and be put on the open market for distribution at your local pharmacy, it must be shown to achieve its intended goal in many people, and its risks or side effects must be well documented.
This would not be possible without first testing the treatment in humans. This test is known as a clinical study.
While not all clinical studies involve testing new treatments, these types of studies may appeal to people with life-threatening diseases or conditions where there are few options for improving their quality of life or prolonging their life.
Many people have found renewed hope through clinical studies, but they aren’t for everyone. So how do you know which study is right for you?
Before beginning any clinical study, it is important for you to know as much as possible about the clinical trial and feel comfortable asking the health care team questions about it.
Some important questions for you to ask will be discussed later. For now, let's talk about the clinical trial process.
People who qualify for any clinical trial should always be told up front what to expect from their participation before choosing whether or not to voluntarily enroll. This process is called “informed consent”.
Informed consent should not end there. It is a continuing process throughout the study to provide you the information you need.
During the initial Inform consent process, doctors and nurses involved in the trial explain the details of the study to help someone decide whether or not to participate. If the participant's native language is not English, translation assistance can be provided.