WHAT IS A MEDICAL RESEARCH STUDY

What is the purpose of this research study?

This is a research study to evaluate the safety and effectiveness of the Biostat System for those with chronic low back pain. The Biostat System consists of a substance called fibrin sealant and a new type of delivery system by which the fibrin sealant is injected into the spine. Fibrin sealant is made from human blood plasma. The use of fibrin sealant to treat low back pain is investigational, although this fibrin sealant has been studied and is used in other medical procedures such as helping to control bleeding during certain types of operations.

How long will the study last and how much of my time is required?

This research study will consist of one visit to the research study center before the study procedure, one visit when the procedure is performed, and then 7 follow-up visits over a period of about 18 months.

What is a clinical trial or research study?

Although there are many definitions, a clinical trial or research study is generally considered to be biomedical or health-related research study in human beings that follows a pre-defined protocol. This is an interventional type study, meaning that you will be assigned by the investigator to the investigational procedure or placebo, and the outcome measured. Your chances of receiving a placebo are 1 in 4.

What happens during a clinical trial?

The clinical trial process depends on the kind of trial being conducted. In all trials, you will first be informed about the trial in detail. After you receive this information, you must give your consent for the trial to proceed. The clinical trial team includes doctors and nurses and may also include social workers and other health care professionals. At the beginning of the trial, your medical condition will be evaluated to determine if you qualify for the study. If you do, you will continue to the next phase of the study. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition.

What is a placebo?

A placebo is an inactive pill, liquid or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. In some studies, the participants will receive a placebo instead of an active drug or experimental treatment.

How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study.

Is it possible to drop out of the study?

Yes, you may withdraw from the study at any time and for any reason. If you stop participating in the study early, the study doctor or study staff may ask you some questions about being in the study. To help you leave the study safely, the study doctor may ask you to participate in more tests (such as a physical examination and blood and urine tests).

Who will be in charge of my care?

The physician at the local study site will be in charge of your care as it relates to the study. However, you are encouraged to inform your primary care physician that you have enrolled in the study.

Will it cost anything to be in this study?

The study procedure and office visits related to this study will be provided to you at no charge for participating in this study. All other costs associated with your medical care, including all medications, will be billed to you and/or your health insurance provider.

Ask your study doctor to discuss the costs that will or will not be covered by the sponsor. This discussion should include the costs of treating possible side effects. Otherwise, you might have unexpected expenses from being in this study.

You may also have additional costs associated with your travel to and from the clinic such as gasoline and parking fees.

Will I be paid to participate in this clinical research study?

Compensation is available for qualified participants. The study site will be able to discuss this with you in further detail.

What are the possible side effects of the study medication or procedure?

If you pre-qualify for this study, the study site will explain the possible risks and benefits of the study with you as part of the informed consent process. By contacting a study site, you are under no obligation to participate in the clinical trial.

Who is performing the study?

The Patient Recruiting Agency in Austin, Texas is recruiting patients for this study on behalf of the company who is sponsoring the study. To avoid potential bias in the study results, the name of the sponsoring company is usually not disclosed.

What are my chances of receiving the placebo?

Your chances of receiving a placebo are 1 in 4.

Why was I excluded from this clinical research study?

Participants must meet specific criteria in order to participate in a clinical research study. Unfortunately, one or more of the answers you gave to the questions asked indicates that you do not satisfy that criteria.

*This information was adapted from the United States National Library of Medicine, National Institutes of Health.