Clinical Trials

Clinical Trials started at KPCO in 1998 with a small group of employees at various locations. In 2002, a formal Clinical Trials office was established to support the conduct of clinical trials throughout the Colorado region.

Now, Clinical Trials consists of over a dozen employees, specifically trained and certified in the conduct of clinical trials and is located at the new Midtown Medical Building. The Clinical Trials department works with the National Institutes of Health (NIH) and various pharmaceutical companies to provide clinical trials for our Kaiser Permanente Members.


Frequently Asked Questions

Below are questions most people ask about joining a clinical trial. It is our aim that we provide you with enough material to allow you to decide whether participating in a clinical trial is right for you.


Clinical trials are research studies designed to improve treatment for patients. Some trials investigate new drugs and treatments while others compare standard treatments against new treatments. Before a new treatment is offered to a patient in a clinical trial, it is carefully studied in the laboratory. All our current standard cancer therapies were once experimental research therapies evaluated in clinical trials. Only after clinical trials show one treatment to be better can that therapy become a new standard treatment. All treatment advances must pass through clinical trial evaluation.

Clinical trials fall into 4 Phases: Phase I - Experimental treatments are evaluated to determine the best dosage and evaluate for side effects. Many treatments do not progress past phase I.

Phase 2* - Once dosage and side effects are known, trials are conducted to get an idea if the new treatment has beneficial effect (a response rate) in a certain disease. More toxicity information is learned.

Phase 3* - The new therapy is compared to the current standard therapy in a randomized trial to see which therapy is better.

Phase 4 - After a therapy or drug is approved and felt to be a standard therapy, many more cases are reviewed in order to detect uncommon side effects or outcomes.

*Kaiser Permanente Colorado primarily participates in phase 2 and 3 clinical trials.

The clinical trial process depends on the kind of trial being conducted (See What are the different types of clinical trials?) The clinical trial team includes doctors and research staff and other health care professionals who:

  • check the health of the participant at the beginning of the trial
  • give specific instructions for participating in the trial
  • monitor the participant carefully during the trial
  • stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results.

Inclusion criteria: The factors that allow someone to participate in a clinical trial
Exclusion criteria: The factors that disallow someone from participating in a clinical trial

These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

If you are thinking about taking part in a clinical trial, here are some important questions to ask:
  • What is the purpose of this study?
  • What kinds of tests and treatments are there?
  • How does this compare to standard therapy?
  • What are my alternative choices for treatment?
  • What side effects can I expect? How does this compare to standard therapies?
  • How long will the study last?

Yes, a participant can leave a clinical trial at any time. Taking part in this study is voluntary. You may decide not to enter the study or may leave the study at any time. Leaving the study will not result in any penalty or loss of benefits to which you are entitled. However, if you decide to stop being in the study, we encourage you to talk with your doctor first about such a choice, so that you are informed about any effects that might have on your health. Your doctor will inform you about any new information related to this study. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

If you are interested in participating in a clinical trial, and your physician finds a trial would be an option for you, you will meet with one of our coordinators. The coordinator will conduct a brief overview of the study and give you a copy of the Informed Consent and HIPAA, along with their contact information. After you make a decision and want to participate, you will meet with a coordinator to sign the HIPPA and Informed Consent. You will be screened for eligibility, and any tests or labs that are needed will be ordered. Once eligibility is established, you will be registered to the study and treatment can begin according to the clinical trial guidelines.