CLINICAL RESEARCH

The Urology Center of Florida is a nationally recognized urologic research center. We are actively engaged in a wide variety of clinical trials that are supported by major pharmaceutical manufacturers and authorized and monitored by the Federal Food & Drug Administration. Participation in medical research allows interested patients the opportunity to receive the most advanced and newest treatments years before they become widely available.

What are Clinical Trials?

A clinical trial is a drug study sponsored by a pharmaceutical or biotechnology company. The purpose of these studies is to find out whether a medication is safe to use and effective against various diseases or medical conditions. In order to study the medication, several questions need to be answered first. For example, what patient population or disease is the drug meant to treat? What criteria should be used for accepting participants into the study? What general and disease-specific information are the study doctors going to obtain?

Essentially, once these and other important study questions are answered, the study doctors (investigators) are chosen, the regulatory documents are approved, and the study is ready to begin.

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Why are Clinical Trials Important?

There are a several reasons why clinical trials are important. First, the participant may have a positive response to the study medication, and their disease or condition may improve. In addition, participants receive free laboratory and medical testing. More often than not, the study medication is in development because it works differently than other drugs on the market, and therefore, it may present an alternative course of treatment for the patient.

Second, participation in a clinical trial helps manufacturers make informed decisions about whether to pursue getting a particular drug approved by the Food & Drug Administration (FDA). Finally, data from one patient (who completes the entire study) can be an important part of a drug development program. In the best-case scenarios, these data can help get an exciting new drug approved by the FDA, and ultimately, continue the industry's efforts in developing medications that are safer, more effective, and work faster than any before them.

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How are a Participant's Rights and Safety Protected?

The FDA is the governing agency that develops the policies and guidelines for all medical research, regardless of manufacturer, study phase, or drug type. There are also independent Institutional Review Boards (IRB) that review and approve all study-related documents, such as protocols, Informed Consent forms, physician credentials and eligibility, and patient recruitment materials, such as print advertisements and public service announcements.

How Can I Find Out About Clinical Trials?

If you are interested in taking part in a medical research project, please inform one of our physicians or study coordinators.

Contact Information

Florida Healthcare Research
3201 S.W. 34th Street
Ocala, Florida 34474
(352) 237-3949
(352) 237-7286 (Fax)
www.floridahr.com

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