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The University of Cincinnati Cancer Center conducts comprehensive research studies in all aspects of cancer care, from cancer prevention, screening, treatment, survivorship, and supportive care.
Before a drug or treatment can be given to cancer patients, it goes through years of testing in cells, tissue cultures, and pre-clinical animal models. The next step is clinical research trials, which are studies involving patients. This process is closely regulated by the U.S. government and monitored by the University of Cincinnati's Institutional Review Board.
The University of Cincinnati Cancer Center Clinical Trials Office manages oncology trials for the UC College of Medicine's clinical departments. There are numerous types of clinical trials, each with a different purpose: prevention, screening, diagnostic, and treatment.
What are the different types of clinical research studies?
These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood or injected into the muscle), how often it should be given and what dose is safe. A phase I trial usually enrolls only a small number (~20) of patients.
A phase II trial continues to test the safety of the drug and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.
In this phase, the experimental study drug or treatment is given to large groups of people to confirm its efficacy, monitor side effects, and compare it to commonly used treatments (or placebo) to get final proof of efficacy and to allow FDA approval of the drug.
After a treatment has been approved and is being marketed, the drug's maker may study it further in a phase IV trial. The purpose of phase IV trials is to evaluate the side effects, risks, and benefits of a drug over a longer period and in a larger number of people than in phase III clinical trials. Thousands of people are involved in a phase IV trial.
Research studies depend on the participation of volunteers. Volunteers help others by contributing to medical research. It is important that research studies include participants from different communities and backgrounds. Diversity in participation will reduce biases and promote health equity.
Study participants will receive expert medical care from study doctors and may get access to new research treatments that are not available outside a clinical trial.
Research studies must have IRB-approved safeguards in place to protect the rights of participants and their personal and health information. The informed consent form for a research study will discuss how your information will be protected and who may see information during the research study. Research studies are required to follow federal rules and regulations to protect participant privacy and information.
The University of Cincinnati Cancer Center Clinical Trials Office manages hundreds of studies for all types of cancer.
231 Albert Sabin Way, Suite 2005Cincinnati, OH 45267Phone: 513-558-2177Fax: 513-558-2666