Clinical Research
Clinical trials play a vital role in pushing forward medical breakthroughs and extending life expectancy, with many of the treatments used today originating from these trials. KU is in an elite group of U.S. universities with top research programs. The Department of Internal Medicine has over 60 research faculty conducting more than 100 clinical trials across different focus areas. Within the Department of Internal Medicine, our committed teams of physician-researchers and scientists work tirelessly to improve the lives and well-being of individuals locally and globally through ongoing clinical research initiatives.
Please join our research registry to learn more about our clinical research studies.
Clinical trials are research studies in which people volunteer to help find answers to specific health questions. Learn more about the basics of clinical trial participation, read firsthand experiences from actual clinical trial volunteers and see explanations from researchers at the NIH Clinical Research Trials and You website.
Clinical trials are research studies in which people volunteer to help find answers to specific health questions. Learn more about the basics of clinical trial participation, read firsthand experiences from actual clinical trial volunteers and see explanations from researchers at the NIH Clinical Research Trials and You website.
The U.S. Food and Drug Administration (FDA) works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. The federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks. Although efforts are made to control the risks to participants, some may be unavoidable because we are still learning more about the medical treatments in the study.
All clinical trials have guidelines, called eligibility criteria, about who can participate. The criteria are based on such factors as age, sex, type and stage of disease, previous treatment history and other medical conditions. This helps to reduce the variation within the study and to ensure that the researchers will be able to answer the questions they plan to study. Therefore, not everyone who applies for a clinical trial will be accepted.
When research only includes people with similar backgrounds, the findings may not apply to or benefit a broader population. The results of clinical trials and studies with diverse participants may apply to more people. That’s why research benefits from having participants of different ages, sexes, races and ethnicities.
Each study will differ based on the type of trial, phase of development and design. Here is what you may typically expect:
- Research staff explain the trial or study in detail, answer your questions and gather more information about you.
- Once you agree to participate, you sign an informed consent form indicating your understanding about what to expect as a participant and the various outcomes that could occur.
- You are screened to make sure you qualify for the trial or study.
- If accepted into the trial, you schedule a first visit, which is called the “baseline” visit. The researchers conduct cognitive and/or physical tests during this visit.
- For some trials testing an intervention, you are assigned by chance (randomly) to a treatment group or a control group. The treatment group will get the intervention being tested, and the control group will not.
- You follow the trial procedures and report any issues or concerns to researchers.
- You may visit the research site at regularly scheduled times for new cognitive, physical or other evaluations and discussions with staff. During these visits, the research team collects data and monitors your safety and well-being.
- You continue to see your regular physician(s) for usual health care throughout the study.
Before joining a clinical trial, it is important to learn as much as possible. Discuss your questions and concerns with members of the health care team conducting the trial. Also, discuss the trial with your health care provider to determine whether or not the trial is a good option based on your current treatment. Be sure you understand:
- what happens during the trial,
- the type of health care you will receive,
- any related costs once you are enrolled in the trial,
- the benefits and risks associated with participating.
Clinical trials of drugs and medical devices advance through several phases to test safety, determine effectiveness, and identify any side effects. The FDA typically requires Phase 1, 2 and 3 trials to be conducted to determine if the drug or device can be approved for further use. If researchers find the intervention to be safe and effective after the first three phases, the FDA approves it for clinical use and continues to monitor its effects.
Learn more about clinical trials design and different phases.
Do you want to participate in a clinical trial that could contribute to medical advancement or lead to a cure? Whether you're a healthy volunteer or someone with an existing medical condition, we're here to assist you in finding the perfect study match.
We invite you to join our research registry. It is a secure database of research volunteers managed by the University of Kansas Internal Medicine Research Operations. You will be contacted by the research staff to receive information on clinical research studies we conduct in our department based on your selection in the survey. It is voluntary, free of charge and you may withdraw at any time. Please join our department research registry to learn more. Fill out the Clinical Research Registry survey to discover ongoing studies.
Health breakthroughs rely on widespread participation in health research. Thank you for considering clinical research — your contribution today paves the way for better medicine tomorrow.