Frequently Asked Questions

Clinical trials test how new medications or treatments work. And they provide patients with access to these promising drugs and treatments. By participating, you also make a contribution to medical knowledge by improving overall cancer care and helping future patients battle the disease.

• A phase I trial is a first step in testing a new drug or treatment approach in people. It determines the drug’s safety, dosage, how patients tolerate it and whether the drug has side effects. This phase usually involves small groups of patients. If the phase I trial is successful, further clinical trials will study the effectiveness of the treatment.
• A phase 2 trial tests the safe dosage of a drug or treatment on a larger group of patients. Researchers define side effects, learn how the drug is used in the body and discover how it helps the condition.
• Phase 3 trials compare the new treatment to the current standard of care. Some participants receive the new drug while others receive the commonly used treatment. Researchers determine if the new treatment is better than, the same as or worse than a standard treatment. This phase may involve hundreds or even thousands of patients at multiple centers.
• Phase 4 trials take place once the new treatment is approved for standard use and put on the market. We do not conduct phase 4 trials at The University of Kansas Cancer Center.

All clinical trials are guided by strict rules monitored by the National Institutes of Health and the Food and Drug Administration.

Before any study can begin at our hospitals, it must be approved by an institutional review board (IRB) made up of medical specialists, nurses and other professionals. As your advocate, the IRB will approve only care that tries to answer medically important questions in a scientific and responsible way.

Each clinical trial has its own set of guidelines regarding who is eligible to participate. Factors generally include age, gender, type and stage of a disease, previous treatment history and other medical conditions.

Timing of your treatment will depend on the current progress of the study. Some patients will have to wait for a period of time before they can begin their clinical trial treatment.

No. Care for patients in a clinical trial is provided in the same way standard treatment is provided. Your physicians, nurses and other health professionals will provide care, keep you informed about your treatment and measure your progress. To ensure reliable results, it’s important for you to follow the care team’s instructions.

Participation in a clinical trial is voluntary. Before you join a study, a member of the research team will meet with you to review eligibility, risks, benefits and details of care and treatment. You are free at any time to change your mind and withdraw from the study.

We are committed to providing you with safe, high-quality care. You are entitled to your rights as a patient, whether you participate in a study or not.

By participating in a clinical trial, you have access to promising new treatments not available elsewhere. You also have access to regular, careful medical attention from a highly qualified care team. Most important, you will contribute to cancer research, which can help other cancer patients in the future.

New treatments aren’t always better than the standard treatments. Also, as a study participant, you may be required to visit the doctor more often than you would with standard treatment. And you may have more blood drawn for laboratory tests.

Some health insurance plans may not cover all care costs involved. However, some state and federal programs help patients pay for care costs associated with clinical trials.