At MU, clinical trials explore potential ways to address illness and injury through carefully designed research studies that answer questions about the safety and effectiveness of medical treatments such as drugs, devices (pacemakers, knee implants and more), types of exercise, nutritional regimens or mental health therapies. Studies may test new treatments or compare existing treatments to determine which works best.
The University of Missouri offers more than 500 clinical trials at various stages in the process of improving health and quality of life.
Whether you are healthy, a patient or the caregiver of a family member or friend, you can register to receive information about participating in clinical trials at MU. To learn more about clinical trial availability and eligibility, please call 573-884-1925 or 1-888-280-5002 (toll free).
How are clinical trials conducted?
In all clinical trials, the researcher creates a protocol that carefully outlines the questions to be answered and the procedures used to collect the information or data. The protocol defines exactly what will be done, when it will be done and by whom. It also describes who may and may not participate as a volunteer in the study. This allows a clinical trial to be conducted at many different locations, or sites, with exactly the same information collected at each site.
Clinical trials are conducted in phases. Phase 1 studies are usually conducted in a small number of healthy volunteers. These are the first people to receive the new treatment. In drug studies, the goal is to determine the correct dose of the medicine and how the body processes and excretes the drug. This also begins the process of discovering any side effects. Participants in these studies may need to stay at the research center for several days.
Phase 2 trials are designed to learn more about the safety and effectiveness of the drug or device. They include more volunteers, often 100-300 people who have the disease or injury the product is expected to treat. These studies may test the new product against a placebo, or inactive medicine. They may also use an existing treatment for comparison. These studies also collect more information about side effects, risks and benefits.
Volunteers are usually assigned to a group randomly, like a coin flip. Participants in the standard care or placebo group are considered “controls” and provide the basis for comparison with the new treatment. Random assignment to the groups ensures that there is no bias in the selection of who receives which treatment.
Phase 3 trials are conducted in larger groups of people with the disease or injury. They may have several thousand participants. Like Phase 2 studies, they may compare the new treatment to an established treatment or to a placebo. In some instances, it could be unethical to use a placebo if a proven treatment is available.
Phase 4 trials are conducted after a new treatment has been approved by the Food and Drug Administration (FDA). Their purpose is to collect information about long-term effects and additional risks and benefits. They may also be conducted in new patient populations, such as children or pregnant women.