Clinical Studies

A clinical study is any research done using human volunteers, or participants, that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials and observational studies.

Clinical Trials

Clinical trials are studies that evaluate the effectiveness of new drugs or treatment strategies. The development of more effective cancer treatments requires that new and innovative therapies be evaluated with cancer patients. In oncology, clinical trials are especially important because, in the absence of high cure rates, nearly all therapeutic approaches are developmental in nature. All new cancer drugs that are currently available in the United States were once only available in clinical trials. Patients should decide whether or not participation in a clinical trial is an appropriate treatment option as early in their evaluation as possible because, once treatment of their cancer has been initiated, patients may become ineligible to participate in some clinical trials.

Clinical Research Groups

In-House Protocols

In addition to participation in multi-institutional clinical trial groups, the Radiation Oncology Department participates in in-house protocols (sets of instructions for treatment, or treatment plans) that are used at the University of Florida. Some involve only the Radiation Oncology Department; many others represent joint effort by two or more departments. Most of these protocols are considered “standard of care” (and are not detailed here), but some are investigational.

Observational Studies

Studies where investigators assess health outcomes in participant groups according to a research plan or protocol are called observational studies. Participants may receive new drugs or procedures as part of their routine medical care, but participants are not assigned to specific new drugs or treatment strategies by the investigator, like in a clinical trial.

Outcome Studies

Outcome studies are necessary to determine the effectiveness of treatment and the severity and number of complications associated with cancer treatment. To perform an outcome study, it is necessary to see patients periodically in clinic after they complete treatment, when possible, and to obtain follow-up information on patients who are no longer able to come in for check-ups. Patients with various types of cancer have their records updated periodically at the University of Florida. Data from these records are analyzed to find out what treatments have been effective as well as those that are less than optimal so that our treatment techniques can be improved.

Outcome studies have been performed annually by all of the faculty and residents in Department of Radiation Oncology at the University of Florida since approximately 1970. During the Department’s annual research seminar in the spring, the results of these studies are presented to visiting radiation oncologists and others from all over Florida and other parts of the country.

Many times these studies are also presented at national or international meetings and published in peer-reviewed journals.


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