What are Clinical Trials?

Clinical Trials are carefully controlled studies that are conducted in volunteers to test the effectiveness and safety of new or old drugs, medical products or techniques. These studies involve people in the testing of new study treatments and therapies and are part of the drug approval process in America. Clinical Trials may also study specific aspects of diseases and conditions to find new information about why people become sick and how they might become healthier. Through clinical trials we make progress in the battle against diseases and conditions and find new treatments.

Some clinical trials seek people that are sick or have certain conditions (such as asthma, diabetes, heart problems) to be studied while other clinical trials need healthy participants.

Do all doctors at the University of Iowa Hospitals and Clinics offer Clinical Trials?

Many doctors are awarded a research grant by the National Institutes of Health, Veteran’s Administration, or receive funding from other groups such as pharmaceutical companies. Some doctors may be funded through their work. All studies must obtain approval to conduct a study from an Institutional Review Board. The review board is composed of physicians, nurses, pharmacists, dentists and other healthcare professionals along with lay people from the community. Members of the Institutional Review Board examine the study's protocol to ensure that the patient's rights are protected, and that the study does not present an undue or unnecessary risk to the patient. The Food and Drug Administration has strict rules the Institutional Review Board must abide by when reviewing a clinical trial.

Second, most subjects that participate in a clinical trial in the United States are required to sign an"informed consent" form. This form explains what the study is about, the risks involved, and what will happen to a patient in the study. Even when a participant signs an informed consent, they have a right to withdraw from the study at anytime. This is always stated in the consent form.

Should I or a member of my family consent to a Clinical Trial?

As a patiet being treated at the UIHC or a possible participant from outside of the University of Iowa Hospital, you may be eligible to take part in a clinical trial. Before anyone can participate in a clinical trial, a healthcare giver that specializes in that particular trial will explain the study to you and review the consent form. Patients considering participating in clinical research should talk about it with their doctors and medical caregivers. If you decide not to participate, this will not in any way interfere with your care. Anyone that considers participation in a Clinical Trial should always ask questions. Important questions to ask may be:

• How long will the trial last?
• Where is the trial being conducted?
• What treatments will be used and how?
• What is the main purpose of the trial?
• How will subject’s safety be monitored?
• Are there any risks involved?
• What are the possible benefits?
• What are the alternative treatments besides the one being tested in the trial?
• Who is sponsoring the trial?
• Do I have to pay for any part of the trial?
• What happens if I am harmed by the trial?
• Can I opt to remain on this treatment, even after termination of the trial?

If you qualify, we hope that you and your family will consider participating in this important role of improving healthcare. Please do not hesitate to talk to your physician about clinical trials that may be available for your participation.

Current Clinical Trials in Internal Medicine

Clinical Trials Available at UI Hospitals and Clinics

University of Iowa Clinical Trials Office

NIH Clinical Trials Website