Before a drug or treatment can be administered to cancer patients, it undergoes years of testing in cells, tissue cultures and pre-clinical animal models. The next step is clinical research trials, which are studies involving patients.

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: treatment, prevention, diagnostic, screening, quality of life and observational.

• Treatment: Tests experimental treatments, new drug combinations or new approaches to surgery or radiation therapy.
• Prevention: Looks 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: Finds better tests or procedures for diagnosing a particular disease or condition.
• Screening: Tests the best way to detect certain diseases or health conditions.
• Quality of Life: Explores ways to improve comfort and quality of life for individuals with a chronic illness such as cancer.
• Observational: Addresses health issues in large groups of people or populations in natural settings by observing and measuring certain outcomes without the use of treatment.

The Clinical Trials Office (CTO) at the Cancer Center conducts comprehensive research studies within all these categories. The research professionals in the CTO serve as key resources for patients, investigators and sponsors on cutting-edge clinical trials that advance science.

Our cancer experts also conduct investigator-initiated trials (IITs), which highlight the breakthrough science happening right here at UC. This progress would not be possible without the dedicated clinical research professionals at the University of Cincinnati Cancer Center Clinical Trials Office. One of these clinical research professionals, in particular, has exhibited exceptional dedication to her patients, role and the growth of the Cancer Center. Her manager, team and the Cancer Center would like to recognize Melanie Margraf and thank her for her contributions.

Melanie Margraf Team Lead & Intake Coordinator Phase I, Experimental Therapeutics University of Cincinnati Cancer Center Clinical Trials Office

“I have always been interested in clinical trials,” Melanie expressed. “Since I was as young as I can remember, my favorite question was always ‘why?’ This natural curiosity has led me to search for answers in oncology. While we do not always know why someone gets cancer, working on trying to find a cure is a huge driver for me.”

Along with the six different types of clinical trials previously mentioned, clinical trials are also typically conducted in four phases, each designed to answer specific questions.

• 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 – approximately 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.

“I find that most people in the general public do not know the difference between each of the phases of clinical trials,” she said. “Phase I trials are first-in-human, and the goal is to see if the medication is safe and to determine the dose. The doctors involved in Phase I trials are looking for signs that the cancer responds to a new treatment, but it is not the primary focus. Phase II trials test if one type of cancer responds to the new treatment. Phase III trials test if a new treatment is better than a standard treatment. Phase IV trials find more information about long-term benefits and side effects.”

After nearly two years with the University of Cincinnati Cancer Center’s Clinical Trials Office, Melanie shared that while there may not be a “typical day” in the office, the work itself and the overall experience is very worthwhile.

“We don’t ever really have a typical day,” she said. “We frequently begin the week by reviewing any urgent needs and working through internal and external referrals. We also spend time in the clinic with our providers to discuss potential trials with patients, perform screenings and review eligibility procedures, and those interactions are so rewarding.”

“We have contact with these patients almost daily for months,” Melanie explained. “I really get to know them, their families and their whole life story. The ability to be there for them through what can be a very scary and uncertain time has been very fulfilling for me.”

Before joining the University of Cincinnati Cancer Center’s Clinical Trials Office, Melanie worked in research and development for various consumer goods. Along with various professional interests, she also enjoys a variety of pastimes.

“Originally, I’m from Cincinnati, but I ventured to Clemson University, where I earned my bachelor's degree in chemistry,” she shared. “After graduating, I spent some time in Michigan, where I gained valuable experience in research and development before returning to Cincinnati. Outside of work, I have a variety of interests that keep me active and engaged. I’m passionate about paddleboarding, kayaking and really anything on the water. I also enjoy equestrian show jumping, which has taught me discipline and perseverance that has served me well professionally. Additionally, I love traveling and exploring new cultures. As we go into summer, after work you will usually find me at Pilates, in my garden or having friends over for a cookout.”