In those clinical research studies that are evaluating an investigational medicine or other form of investigational therapy, volunteers are divided into different groups that each receive a different treatment. Groups might include different doses of the investigational medicine, and usually a “control group” that could be an approved therapy for the condition or a placebo. For example, in a research study evaluating an investigational medicine in the form of a white pill for the treatment of headaches, there could be 3 treatment groups as follows: Group A gets 100 mg of the investigational medicine, Group B gets 50 mg of the investigational medicine, and Group C gets 81 mg of Aspirin. In this type of grouping, the pills in all three groups are manufactured to have an identical appearance, so that neither the research subject or SEC Clinical Research personnel know which treatment is being given.
The process of assigning a research volunteer to a treatment group is referred to as “randomization”. The randomization is usually accomplished by submitting a volunteer’s subject number into a central computer program that randomly assigns that subject to the particular group/treatment. Randomization achieves several goals, which include insuring that each treatment group is assigned the required number of volunteers, and avoids any opportunity for research personnel to select specific treatments for specific research subjects. These procedures help minimize bias that would greatly reduce the validity of the research results.
Randomizations can take several forms, and include “open-label”, “single blind” and “double blind”. These terms are defined and discussed in the Glossary.