What’s Involved in Participating in a Clinical Research Study?

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What’s Involved in Participating in a Clinical Research Study?

When you participate in a clinical research study at St. Alexius Medical Center, you are given a number. But that number does not reflect the importance we place on your contributions to the advancement of medical research.

The number simply protects your privacy as a participant in one of our ongoing clinical research studies designed to test the effectiveness of a new drug or treatment method. Because your well being is our priority, we are committed to providing you with the opportunity to participate in the most recent clinical treatments and therapies available that may improve your condition and quality of life. We find that study participants share our concern about minimizing the discomfort of those who suffer the same illnesses or disorders.

For more than 14 years, the staff at Clinical Research Services and St. Alexius Pharmacy have been participating in studies that have contributed substantially to the advancement of medical knowledge. Through these studies, new drugs and treatments have become available to help people from such illnesses and disorders as chronic pain, heart disease, hypertension, cystic fibrosis, breast and lung cancers, asthma, osteoporosis, infectious diseases, gastrointestinal disorders, sinusitis, influenza and end-stage renal disease.

WHAT YOU CAN EXPECT

Before you can participate in a study, you must meet certain requirements. First, you must be experiencing the illness or disorder and meet criteria established by the study plan. You

must also be able to understand and sign the informed consent. Sometimes, the study requires that you must not be suffering from kidney or liver disorders.

As a study participant, you will undergo a physical examination, and your physician or a research staff member will review your medical history. The informed consent describes the rationale for the study, risks and benefits of the medication or treatment, and procedures involved in the study. We take time to make sure that you fully understand what is involved in participating in a

particular study. Participating in a clinical research study requires a commitment by you to take medications as directed and to complete the study. Depending on the study’s scope, you may be required to keep a daily log or at least jot a few notes describing problems experienced between appointments. The time between appointments also depends on the study s requirements.

BENEFITS FOR YOU

A trial study provides you with a chance to try a new treatment that may prove to be more effective than past treatments. Because you are the one who is providing needed insight, you do not pay for your treatment. And, you have access to high quality medical care.

We also take precautions to ensure your health is protected. If you are receiving a placebo, or we determine that the treatment is not adequate, we find alternate treatment for you at no additional cost. We do so through the support of the 150-plus member physicians of our PrimeCare health group. Without volunteers, we could not conduct clinical studies, and without new clinical trials, new drugs and therapies would not be available. For additional information, contact our office at 530-6950.

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