Clinical Trials at CU Cancer Center

Clinical trials are research studies that involve people. They are the final step in a years-long process that begins with research in a lab and animal testing. Many treatments used today are the result of past clinical trials. Clinical cancer trials are designed to answer questions about new treatments or new ways of using old treatments and how well they work. These trials may test drugs or vaccines, ways to do surgery or give radiation therapy or combinations of many treatments. Your doctor may offer you the option to join a clinical trial as part of your treatment plan.

Clinical cancer trials follow very strict rules, called protocols, that are overseen by a governing scientific and ethical body. The protocol will determine who can participate in the trial and help make sure the trial is safe and has accurate and meaningful results.

Contact A Clinical Team

Clinic	Clinic Phone Number
Brain Cancer Clinic	720 848 0408 Opt.1
Breast Oncology Clinic	720-848-1030
Melanoma/Mohs Oncology Clinic & Scheduling	720-848-0590
Gastroenterology Oncology Clinic & Scheduling	720-848-3532
Genitourinary Oncology Clinic	720-848-0170
Gynecologic Oncology Clinic and Scheduling	303-724-2066
Head & Neck Oncology Clinic	720-848-3532
Thoracic Oncology	720-848-3386
Phase 1 Team	720-848-1543
Radiation Oncology Clinic	720-848-0293

Cancer Clinical Trials Office

The Cancer Clinical Trials Office (CCTO) provides support to clinical investigators on all activities related to the successful conduct of clinical trial research. This is the cornerstone to translate basic science knowledge of the cancer process into clinically useful treatment for patients.

Mission & Objectives:

The mission of the CCTO is to support the "develop" portion of the broader CU Cancer Center mission to discover, develop, and deliver breakthroughs in diagnosis, treatment, and prevention that improve cancer care.

Support all aspects of clinical investigations including protocol development, patient recruitment and treatment, coordination of care with other clinical services
Perform all aspects of regulatory compliance and quality assurance
Facilitate CU Cancer Center investigator-initiated cancer clinical trials
Provide clinical trials education to investigators, research staff and clinic personnel
Provide fiscal and operational excellence leading to cost-effectiveness

Clinical Trial FAQ's

A clinical research study, often known as a clinical trial, is a way to find answers to difficult scientific or health questions. Results from these studies can lead to the approval of new medicines to treat diseases such as cancer.

Research Studies can range from being small and locally based, to worldwide efforts enrolling thousands of participants. Participants might have a specific disease or condition, or they may be healthy volunteers.

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.

Clinical trials are completed in phases. If a new drug does not pass any phase then it cannot move to the next. Each phase generally increases the number of subjects and may move from a treatment of last resort with a general population of advanced cancer patients to a treatment of choice with a more targeted population in which the drug has been shown to work especially well.

The goal of Phase 1 clinical trials is to test a drug’s safety. In this phase, doctors can also learn more about correct dosage, side effects, when and how often it should be taken, and how the cancer responds to the treatment. Typically, there are anywhere from 10 to 30 people in a Phase 1 clinical trial, which can last from months to a year
Phase II clinical trials refine researchers’ understanding of drug safety and efficacy. 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 dosing levels. Participants on a Phase II clinical trial may be asked to keep logs about how they are feeling. These trials last about two years and have under 100 patients.
Phase III clinical trials compare the new therapy to the current standard of care. 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 at random to either be treated with the new therapy or with the standard of care (most cancer clinical trials do not include a placebo). Many trials are designed such that if the first cohort of patients shows benefit, the trial design changes so that the “control” group is also offered the new drug. The FDA will typically not approve a drug to be used in the general public unless it passes a Phase III clinical trial. Commonly, 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 drug over time and in a large population to watch for late-onset side-effects and to refine their use of the drug, perhaps in combination with other drugs, at different disease stages, and in more focused patient populations.

For more information about clinical trial phases click here.

Be sure you understand what happens during the study, the type of health care you will receive, any related costs, and the benefits and risks of participating.

A clinical research study is different from regular medical care. Unlike medical care, when your Doctors make decisions about the goal of treating your disease or condition the best they can, research seeks to answer a research question. The researchers might not be able to treat you as they would if you were their patient.

In some studies, researchers need to compare healthy volunteers with people who have a specific disease or condition. Research with healthy volunteers is designed to develop new knowledge, not to provide direct benefit to study participants.

Don't be afraid to ask the research team for more information and talk with them about your concerns. It is their job to provide you with the information you need to make your decision.

More information:

Questions to ask when deciding whether to volunteer for research:

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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 easing the burden of cancer for future patients. From basic laboratory researchers to the doctors administering treatments, no one takes clinical trials lightly. 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.

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

Cancer Center Clinical Trial Locations

Anschutz Medical Campus

Lone Tree Location

Highlands Ranch

Cherry Creek

Clinical Trial Resources

Cancer Center (SOM)

CU Anschutz

Anschutz Cancer Pavilion

1665 North Aurora Court

2004

Aurora, CO 80045

720-848-0300

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Clinical Trials Save Lives

Clinical Trials Save Lives

Clinical Trials Save Lives

Clinical Trials at CU Cancer Center

Contact A Clinical Team

Cancer Clinical Trials Office

Mission & Objectives:

Clinical Trial FAQ's

Additional resources

More information:

Cancer Center Clinical Trial Locations

Anschutz Medical Campus

Lone Tree Location

Highlands Ranch

Cherry Creek

Clinical Trial Resources

Cancer Center (SOM)

CU Anschutz

Anschutz Cancer Pavilion

Clinical Trials Save Lives

Clinical Trials Save Lives

Clinical Trials Save Lives

Clinical Trials at CU Cancer Center

Contact A Clinical Team

Cancer Clinical Trials Office

Mission & Objectives:

Clinical Trial FAQ's

What is a clinical trial?

What are the phases of a clinical trial?

What do I need to know before participating?

Why are clinical trials important?

What is an investigator-initiated trial (IIT?)

Cancer Center Clinical Trial Locations

Anschutz Medical Campus

Lone Tree Location

Highlands Ranch

Cherry Creek

Clinical Trial Resources

Cancer Center (SOM)

CU Anschutz

Anschutz Cancer Pavilion