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?

• Treatment - Test experimental treatments, new combinations of drugs or new approaches to surgery or radiation therapy.
• Prevention - Look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, immunizations, vitamins, minerals, or lifestyle changes.
• Diagnostic - Find better tests or procedures for diagnosing a particular disease or condition.
• Screening - Test the best way to detect certain diseases or health conditions.
• Quality of life - Explore ways to improve comfort and the quality of life for individuals with a chronic illness such as cancer.
• Observational - Address health issues in large groups of people or populations in natural settings by only observing and measuring certain outcomes without the use of treatment.

Phase I
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.

Phase II
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.

Phase III
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.

Phase IV
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.

Many steps are taken to protect the safety of participants, including ensuring well-designed research that satisfies all rules and regulations. However, some research does involve risks. Research can only be conducted with the approval of an Institutional Review Board (IRB). The IRB is an independent group of experts who are responsible for deciding whether the research should happen. They also provide continued oversight as the research progresses. The IRB reviews the benefits of the research to see if they outweigh any risks, and they review the studies to make sure they are ethical. At the University of Cincinnati Cancer Center, research participant safety is of utmost importance and taken very seriously with many layers of patient safety in place. This includes making sure participants understand the risks and benefits of the research before agreeing to participate.

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.