Clinical Trials
At the KU Clinical Research Center, our highly trained staff ensures optimal care for people participating in clinical trials.
Care, comfort and convenience
Our team is dedicated entirely to the KU Clinical Research Center and includes research nurse clinicians, clinical pharmacologists, research study coordinators, oncology nurse coordinators and medical assistants.
Our facility offers:
- Oncology exam suite with 10 private rooms and a room for minor procedures
- Oncology treatment suite with 17 private rooms, draw stations and consult room
- Clinical lab for performing complete blood counts, blood chemistry analysis, urinalysis and preparation of bone marrow biopsies
- Central and easily accessible area of metropolitan Kansas City
- Parking only steps from the building entrance
- Private, comfortable and sound-resistant rooms
Participating in a clinical trial
Deciding whether to participate in a clinical trial is an important choice that you should make only after consulting with your loved ones and your doctor. But first, you should understand what is involved in a clinical trial. Write down all the questions you have and any concerns of your family members. Through your own research and discussions with your doctors, make sure all of your questions are answered. Then you can be confident that you are ready to make an informed decision.
Clinical trials are research studies that include human participants to test possible new medical treatments before they can be federally approved for use in the general public. The research aims to prevent, treat, control or diagnose a disease or condition, but it must be tested to determine its safety, side effects and effectiveness.
The medical treatments that are being administered to patients today started out in clinical trials. Each treatment being tested has the potential to be tomorrow's standard of care. The research process for a new treatment from the lab to the market can take years and even then, only a small percentage are ever approved as a standard treatment.
A promising new drug or treatment developed in the laboratory must be thoroughly tested and undergo several phases before being approved:
- Phase 0: Determine how a drug is absorbed, distributed and metabolized within the body to determine its promise for future testing.
- Phase I: A drug is tested in a small group of people (20-80) to determine safety, dosage and side effects.
- Phase II: The drug is given to a larger group (100-300) for further safety evaluations and effectiveness.
- Phase III: The size of the study group is significantly expanded (1,000-3,000) to confirm drug effectiveness among a more diverse population. The drug is compared to how well it works versus standard treatments.
- Phase IV: After the drug is approved for consumer use, these trials by the drug manufacturer determine more information about the treatment's effectiveness, in comparison with other drugs.
Clinical trials have different eligibility guidelines based on age, gender, type and stage of a disease, previous treatment history and other medical conditions. Some seek participants with specific illnesses or conditions, and others seek healthy volunteers.
Check the guidelines of the study you are considering, talk with your doctor or contact the researcher. Your doctor may suggest a trial, or you can search for studies on your own.
A website, www.clinicaltrials.gov, is a one-stop registry of federally and privately supported clinical trials being conducted in all 50 states and 176 countries around the world.
You will be cared for in a hospital or clinical setting and have a research team that may include doctors, nurses, social workers, dietitians or other health care professionals who provide your care, monitor your health carefully, and give you specific instructions about the study.
Participating in a trial may mean that you might have more tests and doctor visits than you would if you weren't in the study. Team members also may continue to stay in contact with you after the trial ends.
To make the trial results as reliable as possible, it is important for participants to follow the research team's instructions. That means having all doctor visits and tests, taking medicines on time, and completing logs or answering questionnaires.
The unknown element inherent in clinical trials a big factor to consider. You may get better, you may see no change, or you may get worse. Your participation in the study will determine whether a treatment is effective or not. Weighing the potential benefits and risks involved in a clinical trial is a very important part of deciding whether to participate.
Benefits
- Gain access to new research treatments before they are widely available
- Obtain expert medical care at leading health care facilities during the trial
- Help others by contributing to medical research
- Play an active role in your own health care
- You may be among the first to benefit if the approach being studied is found to be helpful
Risks
- Side effects may be unpleasant, serious or life-threatening
- The experimental treatment may not be effective for the participant
- The protocol may require more time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements
Coverage and costs will vary from person to person depending on the benefits provided by your employer, insurance company and type of policy. Some plans do not cover any care/costs while enrolled in a clinical trial because the treatment is deemed experimental. The costs associated with the clinical services provided while enrolled in a clinical trial fall into two general categories: patient-care costs and research-care costs.
Patient-care costs include any clinical service that the organization sponsoring the study will not cover. These services/costs are generally those that would normally be covered for treating your condition, whether or not you are enrolled in a clinical trial. These costs may not be covered by your employer/insurer, which would result in your being liable for the costs. The hospital does offer financial assistance for those costs not covered by your employer/insurer but such assistance may not offset your out-of-pocket costs.
Research-care costs are generally those services done solely for the purpose of the clinical trial, which often would not be provided if not for participating in the trial. These costs can include tests performed to analyze the research or its results as well as the costs associated with the research doctor's time. Such costs are usually covered by the organization sponsoring the trial.
Your best course of action is to check with your employer, your insurance company and the research organization to fully understand what will or will not be covered prior to your participation in the clinical trial.
For guidance on working with your insurance company to cover your participation in a clinical trial, read these guidelines from the National Cancer Institute.
How to Participate
Would you like to talk to someone about participating in clinical research?
- For cancer trials, visit the KU Cancer Center website or call 913-945-7552.
- For Alzheimer's disease or brain health studies, visit the KU Alzheimer's Disease Research Center website or call 913-588-0555 (choose option 1).
- For information about other clinical trials, call the Frontiers Clinical and Translational Science Institute's helpline at 913-945-7518.