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 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.
- 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.
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.
- 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?