One way researchers can isolate the effects of a study treatment is through randomized controlled trials. This is helpful when comparing the investigational treatment to the standard of care. Participants are randomly assigned by a computer to either the “investigational group” that receives the investigational therapy or a “control group” that receives the standard treatment. Randomly assigning participants helps to create two similar groups for comparison.
Trials may be designed in a variety of ways. Some have no control group, while others may have a control group and more than one investigational group, in order to test different dosing or treatment combinations.
In addition, some trials are “blinded”. In single-blinded trials, the participants don’t know which treatment they are receiving until the trial is over. In double-blinded trials, neither the participants nor their doctors know which treatment is being given.
Blinding helps to prevent bias in terms of how patients and their doctors might perceive or report how they’re doing.
Patients in both groups, experimental and standard of care, are closely monitored by the doctors on the study.