Urology Research Department

Participate in a Research Study

What is a Clinical Trial?

A clinical trial is a research study in human volunteers carefully designed to answer specific health questions. Clinical trials are generally used to identify new ways to treat, prevent, or diagnose diseases. People who meet specific eligibility criteria and choose to participate in a clinical trial are partners in this research process. They receive close medical supervision during the study and provide valuable feedback on their experiences.

The Food and Drug Administration (FDA) and Institutional Review Boards (IRBs) carefully review all clinical trials and make sure participants’ rights are fully protected and that they are not exposed to any unnecessary risks. Carefully conducted clinical trials sponsored by the government or a private company are considered the standard way to find treatments that work. Today, any medication your doctor prescribes has gone through the clinical research process.

Before our Urology Research Department can start a clinical research study, it has to be reviewed and approved by a group of people called an “Institutional Review Board,” or IRB. The IRB is an independent group of individuals comprised of medical, scientific, and non-scientific members whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a clinical trial. The IRB must review, approve and provide continuing review of all research protocols being conducted. The IRB must approve the protocol, informed consent, any literature given to the patient, and advertisements used to recruit patients.

Where do Research Patients come from?

Only patients who volunteer get to join a study.

Many patients may be asked to participate in a clinical trial, but only those who agree to participate actually take part.   The Urological Institute of Northeastern New York is committed to doing research only when the subject will get to decide if they want to participate.  We believe the people who volunteer to participate in clinical trials are very special because they are helping to improve the future of health care.

Who should volunteer to participate in a clinical trial?

Clinical Trials are not always “the last resort”. There are many other reasons to volunteer your participation:

• You may learn more about your disease or condition.
• You may be seen more frequently or have additional tests that you would not receive as part of your regular care.  These tests and visits are usually paid for by the sponsor and not billed to you or your insurance.
• Your participation may not be of a direct benefit to you, but it may help future generations who have the same condition.
• You would be able to receive investigational medications that you would not have access to otherwise.
• The current available medications may not be helping your disease or medical condition.

What do you need to consider before volunteering?

• You should carefully review the material supplied to you to make sure you want to volunteer.
• Investigational drugs are not always better than the current available drugs, but we do not know this until they are tested.
• Subjects in randomized trials do not get to choose which group they are in.
• You may have to come in for additional visits or have additional tests done.
• Even if the drug is proven effective for some participants, it may not benefit you, just as standard treatments do not work for everyone.
• Investigational drugs, just like all medications, have side effects or risks.  Ask about the side effects known to date and remember there is a chance you may have a side effect that have not yet been discovered.

Patient care and safety are our top priority. Whether you participate in a clinical trial or not, your health and safety are our top priority.

If you are a volunteer in a clinical trial, we are particularly interested in any side effects or health problems that you have.  You should always follow the directions you are given by the study staff on how to report side effects so they can be treated if necessary.

In order to decide if a clinical trial is right for you, you should weigh the risks and benefits.  Ask a family member to accompany you to the visits or review the material provided to you to help you make your decision. Only you can decide if volunteering for a clinical trial is right for you.

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