Advances in cancer prevention, screening and treatment begin with research. At the University of Cincinnati Cancer Center, comprehensive research studies span all aspects of cancer care—from cancer prevention and screening/diagnosis to cancer treatment, side effect management and quality of life improvements for cancer patients and survivors.

One important part of this research is clinical trials. Clinical trials are carefully designed research studies that test new medical approaches in people. They help researchers determine whether new treatments, screening methods, prevention strategies and supportive care approaches are safe and effective.

Why Are Clinical Trials Important?

Before a new drug or treatment can be tested in people, researchers study it for years in laboratory experiments, tissue cultures and preclinical animal models. Clinical research is the next step in this process, allowing researchers to understand how a new approach works in people and whether it may ultimately benefit patients.

Clinical trials also help researchers improve existing approaches to cancer care. Results from clinical trials have contributed to many of the treatments and screening methods available today and continue to shape the future of cancer care.

The University of Cincinnati Cancer Center’s Clinical Trials Office manages hundreds of oncology studies across the UC College of Medicine's clinical departments, covering many types of cancer and areas of research.

Emily Curran, MD Medical Director, Clinical Trials Office University of Cincinnati Cancer Center

Michelle Marcum, MS Administrative Director, Clinical Trials Office University of Cincinnati Cancer Center

What Types of Clinical Trials Are There?

Not every clinical trial tests a new cancer treatment. Different studies are designed to answer different research questions.

• Treatment trials test new treatments, combinations of existing treatments or new approaches to surgery, radiation or other therapies.
• Prevention trials explore ways to prevent cancer from developing or reduce the risk of cancer returning. These approaches may include medications, vaccines, vitamins, lifestyle changes and other strategies.
• Screening trials evaluate new or improved ways to detect cancer before it causes symptoms, when it may be easier to treat.
• Diagnostic trials explore new tests or procedures that may help doctors identify cancer or better understand a patient's disease.
• Supportive care and quality-of-life trials investigate ways to manage symptoms and side effects and improve comfort and well-being during and after cancer treatment.
• Observational studies collect information about people's health without assigning a treatment. These studies can help researchers identify patterns and better understand cancer and other health conditions in large groups of people.

Understanding the Phases of Treatment Trials

When a clinical trial tests a new drug or treatment, it generally moves through several phases. Each phase has a different purpose.

• Phase I: Researchers study a new treatment in a small number of people to determine how it should be given, how often it should be given and what dose is safest.
• Phase II: Researchers continue to evaluate safety while beginning to study how well the treatment works. These studies often focus on people with a specific type of cancer.
• Phase III: The treatment is tested in a larger group of people to confirm its effectiveness, monitor side effects and compare it with commonly used treatments or, in some cases, a placebo. Results from phase III studies can help support regulatory approval.
• Phase IV: After a treatment has been approved, researchers may continue studying it in much larger groups of people to better understand its long-term benefits, risks and side effects.

It's important to remember that not every clinical trial follows this exact sequence. The design and requirements depend on the research question and the type of study being conducted.

Are Clinical Trials Safe?

Participant safety is a central priority throughout the clinical research process. Clinical trials must meet strict rules and regulations, and research involving people requires approval and ongoing oversight from an Institutional Review Board (IRB).

An IRB is an independent group of experts that reviews research studies to make sure they are ethical and that the potential benefits of the research justify its risks. The IRB also provides continued oversight as the study progresses.

Before joining a clinical trial, participants receive information about the study, including its purpose, potential benefits, possible risks and what participation involves. This process, called informed consent, gives individuals the opportunity to ask questions and make an informed decision about whether participating is right for them.

How Is Your Information Protected?

Protecting participants' privacy and personal health information is another important part of clinical research. Studies must have safeguards approved by the IRB to protect participants' rights and information.

The informed consent process explains how a participant's information will be used and who may have access to it. Clinical research studies also must follow federal requirements designed to protect the privacy and security of participants' information.

Who Can Participate in a Clinical Trial?

Clinical trials may be available to people with cancer, people who have certain risk factors for cancer and, for some studies, people who had cancer in the past, or healthy volunteers. Eligibility depends on the specific research question and may include factors such as cancer type, stage, previous treatments, overall health, age or other characteristics.

A clinical trial may or may not be the right option for an individual. Patients interested in clinical research should talk with their health care team about whether a trial may be appropriate for them and how it fits into their treatment options.

Moving Cancer Research Forward

Every clinical trial is designed to answer an important research question. By participating in research, patients and healthy volunteers can contribute to a greater understanding of cancer and help researchers develop better ways to prevent, detect and treat the disease.

At the University of Cincinnati Cancer Center, clinical research is an important part of the Cancer Center's commitment to advancing cancer care. Through studies spanning prevention, screening, diagnosis, treatment and supportive care, researchers are working to turn discoveries into better options for patients today and in the future.

Interested in learning more? Talk with your doctor or health care team about clinical trials that may be appropriate for you.