Clinical Trials are organized studies conducted with volunteers to answer a particular question about a treatment. A new drug that has been developed must go through a series of tests. These tests cannot predict exactly how the new treatment will work in people or determine all the side effects that might occur.
Clinical Trials are designed to find out the safety and effectiveness of a treatment in humans. Clinical Trials provide new treatments that might otherwise be unavailable because the Food and Drug Administration (FDA) has not yet approved the drug. Clinical Trials are carried out in one to four different phases. These phases are designed to answer different questions. Volunteers are eligible for participating in all of the different phases of studies.
All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must qualify for the study. The factors that allow volunteers to participate in a clinical trial are called “inclusion criteria” and the factors that disallow volunteers from participating are called “exclusion criteria”. These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Some research studies seek participants with specific illnesses or conditions to be studied in a clinical trial, while others require healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participants’ safety, and ensure that researchers learn the information they need.
As a volunteer in a clinical trial, you are participating in the development of medical therapies – therapies that may offer better treatments and even cures for life-threatening chronic diseases.
People volunteer to participate in a clinical trial for a number of reasons. You may get involved in a trial because you simply want to help in the advancement of science. Or you may be suffering from a disease for which a good treatment does not currently exist. You may join a clinical trial hoping to improve the medical care you receive. If you do not have health insurance, clinical trials are a way to receive study-related medical care.