Clinical Trials at the CU Cancer Center

A clinical research study, often known as a clinical trial, is a way to find answers to difficult scientific or health questions.  For example, clinical trials can help us learn how best to screen for cancer, so patients know earlier, when the cancer is more likely to be treatable.   Results from these studies can lead to the approval of new ways to detect and treat diseases such as cancer.

Clinical trials can range from being small and locally based, to worldwide efforts enrolling thousands of participants.  People who participate might have a specific disease or condition, or they may be healthy volunteers.

Check out our Clinical Trials Education session you can complete virtually, and get paid $25 for completing a survey to learn more. 

Additional Resources

OHRP has created a series of short videos with information about how research works, what questions you should consider asking, and things to think about when deciding whether to participate in a study.

• Why Do Researchers Do Different Kinds of Clinical Studies? (NIH)
• Learn more about clinical trials (FDA)
• Clinical Research FAQ (NIH)
• Clinical Trials Information for Patients and Caregivers (NCI)

Clinical trials are completed in phases. If a new treatment does not pass any phase, then it cannot move to the next. Each phase generally increases the number of people participating and is asking a different question:

• The goal of Phase 1 clinical trials is to test a treatment’s safety. In this phase, doctors can also learn more about how much to give a patient,  what the side effects are, and how the cancer responds to the treatment. Typically, there are anywhere from 10 to 30 people in a Phase 1 clinical trial.
• Phase II clinical trials determine whether a treatment is effective or not. Sometimes participants are separated into two or more groups. This is done to see how a new therapy compares to the standard of care or to try different amounts of the treatment. Participants on a Phase II clinical trial may be asked to keep logs about how they are feeling. These trials have under 100 patients.
• Phase III clinical trials compare the new therapy to the current standard of care, or what is currently being used in clinics to treat the disease. In this phase, the trial evaluates side-effects and effectiveness and tries to define whether one treatment works better than the other. In many cases people on Phase III clinical trials are chosen randomly to either be treated with the new therapy or with the standard of care (most cancer clinical trials do not give people a placebo, or sugar pill). The FDA will typically not approve a drug to be used in the general public unless it passes a Phase III clinical trial.  Phase III clinical trials include more than 100 people.
• The last phase of clinical trials is Phase IV. During this phase, drugs that are newly approved by the FDA are tested in hundreds or thousands of participants. This allows doctors to collect more information about the treatment over time and in a large group to watch for longer-term side-effects.

For more information about clinical trial phases click here.

Clinical trials allow doctors and researchers to test treatments that will extend lives and, increasingly, even lead to cures for some forms of the disease. Some patients will benefit from some clinical trials. Other patients understand that their involvement contributes to helping future patients. In these essential tests, it is the bravery and hope of human patients that allows cancer science to truly reach its goal of providing new treatments. 

It is important that people from all backgrounds participate in clinical trials.  If a treatment is only tested in one type of person, doctor’s are unable to determine how the treatment reacts for ALL different types of people.

Investigator-initiated trials are “homegrown” ideas from researchers and investigators who are active in lab and clinical settings. The sponsor investigator of the trial is not only sponsoring the study but also conducting it. This means that they will be in charge of creating, coordinating, and carrying out the IIT. This may be done alone or with a team supporting the sponsor investigator.

• Learn more about IITs