Southwest Kidney Institute’s research department exists to provide patients with leading specialty pharmaceutical and device study options in accordance with our model of excellence in accordance to the SKI continuum of caring. Through our research program, investigational and post-market drugs and devices are available on a voluntary basis that not only furthers development of new scientific products and theories, but also give the patient cutting-edge options that may not be otherwise available to them. All studies are considered based on a Hippocratic model of benefit and significance to our patients. Our research staff consists of medical professionals with an extensive accumulation of research, nursing, and physician experience, which insures our patients are followed diligently and carefully throughout the course of the research participation.

We currently have studies underway in the pharmaceutical treatment areas of diabetic nephropathy, iron deficient anemia, phosphorus control, lupus nephritis, and other processes associated with chronic kidney disease and end-stage renal failure. In our interventional nephrology suites, we participate in dialysis catheter, A/V stent as well as other device studies including investigational products to extend and prevent infection in long-term catheter patients.

• Gaining access to medical care that may not be available to the general public
• Treating a condition for which there is no effective treatment today
• Helping advance medical science
• Obtaining study-related medical care and medications at no cost
• Compensation for time and travel associated with participation

What is a Clinical Trial?

Clinical trials, also known as research studies, are conducted to test the safety and effectiveness of new medications and treatments or to develop new uses for existing medications and treatments. These trials are conducted at approved sites under the supervision of physicians (also called investigators) and other research professionals.

Why should patients volunteer?

Participating in a clinical trial is much like a regular visit to a doctor's office. Volunteers are treated professionally and with care. During a clinical trial, study medication is administered and treatment is given according to a protocol that research professionals must follow. The advantages of participating in a clinical trial may include:

• Obtaining study-related medical care and medications at no cost
• Gaining access to medical care that may not be available elsewhere
• Treating a condition for which there is currently no effective treatment
• Helping advance medical science

Whatever the reason, it is important that patients make an informed choice about volunteering for a trial.

Who can participate?

Each trial has different guidelines for determining who is eligible. These guidelines are usually based on several characteristics including type of disease, current medical condition, medical history, and age. A doctor or another research professional will perform a thorough physical exam and medical history to determine if you are eligible to participate.

What happens during a trial?

If you are eligible for a trial, you will be assigned to a specific study group. Depending on the group, you will receive either:

• The investigational medication or treatment
• A placebo (an inactive product that is used to compare the results of the actual medication or treatment)
• An already approved medication or treatment

How are patients informed about the progress of a trial?

Informed consent is an important part of the clinical trial process. Before volunteering for a study, you will be given detailed information about a study to help you make your decision on whether or not to participate. If you decide to volunteer, you will be asked to sign an Informed Consent Form. During the trial, research professionals will keep you updated on the progress of the trial and you will be asked to re-sign consent if changes and/or new discoveries are made during the trial. You are encouraged to ask questions and can expect honest answers from your doctor and/or research coordinator.

How is a patient's privacy protected?

All medical records are kept confidential. The trial data provided to study sponsors and the US Food and Drug Administration (FDA) does not include identifying information.

Are clinical trials safe?

The FDA has strict guidelines for conducting clinical trials in all areas of medicine. They require that all medications and/or treatments be thoroughly tested for safety and effectiveness before they can be prescribed by a doctor. The government, pharmaceutical and biotechnology industries have developed standard guidelines that all clinical research sites must follow in order to conduct clinical trials. Audits are performed on a regular basis to make sure the guidelines are being followed. Additional review is done by organizations called Institutional Review Boards (IRB). These boards make sure patient's rights are fully protected and that you are not exposed to any unnecessary risks.

What happens when the trial is over?

Once the trial is complete, all the information is analyzed to determine whether the treatment is effective and safe. From there, the FDA decides whether or not to approve the medication and/or treatment. This process can take anywhere from five to fifteen years.

Who are trials sponsors?

Study sponsors can be pharmaceutical, biotechnology or medical device companies. Studies may also be conducted through large organizations such as medical universities or the National Institutes of Health (NIH).

Who pays for the trial?

The study sponsor usually pays for all procedures, lab work and medications directly related to the trial. Your doctor or a clinical research coordinator can give you more information about the study you are considering.

What questions should patients ask before participating in a clinical trial?

• What is the purpose of the study?
• What kinds of procedures and/or tests will I have during the study?
• How often will I need to go to my doctor's office?
• What are my responsibilities during the trial?
• Are there medication restrictions during the study?
• What are the potential benefits and possible risks?
• How long will I be in the study?
• Will there be any cost to me?
• Is there alternative treatment for my condition?
• Will I learn of the study results?

These questions are answered in the informed consent form that is given to you if you decide to participate. You should speak with your doctor or a research coordinator for more information about getting involved in a clinical trial.

Where to find more information about clinical trials

National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892
(301) 496-4000
http://www.nih.gov

http://www.centerwatch.com
http://www.clinicaltrials.com
http://www.clinicaltrials.gov