We understand that the decision to participate in a clinical study requires you to consider a number of factors. The scientific language used is often hard to understand. This glossary is aimed to define some of these scientific terms.
Blinded: This study design is often used in studies which compare two different treatments. Blinding prevents the participant from knowing certain information that might lead to a bias on their part.
FDA: The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. The FDA is responsible for protecting public health through the regulation and supervision of health products like pharmaceutical drugs, vaccines, medical devices and veterinary products.
Investigational: The sinus product being studied in RESOLVE II is considered investigational because it has not been approved for commercialization by the United States Food and Drug Administration (FDA). The RESOLVE II Study is evaluating its safety and effectiveness. The data collected during the RESOLVE II Study will be used to obtain the FDA approval for this product.
IRB: An Institutional Review Board (IRB), also known as an independent ethics committee or ethical review board, is a committee that approves, monitors, and reviews biomedical and behavioral research involving humans. The purpose of an IRB review is to ensure that appropriate steps are taken to protect the rights and health of patients in a research study.
Multi-Center: A multi-center trial is a study which is conducted at more than one site of patient care. For example, the RESOLVE II Study will enroll patients at 45 US centers. Multiple centers of study ensure that the study enrolls participants from various geographic locations and are represented by different ethnic groups and gender.
Control Group: A control group is a group of patients in a clinical trial that does not receive the treatment being studied, so that comparisons can be made between the two groups. For example, in the RESOLVE II Study, the participants in the control group will not receive the new treatment option, but will take an FDA-approved topical steroid spray and will undergo the same level of care as the participants who receive the new treatment option. The results of the control group are compared to the results of the treatment group, and that data is used to decide if the new treatment option is effective in treating the disease. Without the control group, there would be no way to compare the new treatment option to the current treatment options.
Prospective: A prospective study observes the participants over a pre-defined time of period set at the start of the study. Various results are collected at regular time intervals to measure the effectiveness of the investigational treatment.
Randomized: A randomized study design randomly assigns participants in the study to either the control or the treatment group. A randomized design is used to prevent bias on the parts of the participants and the doctors administering the investigational treatment.