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At Boulder Community Health we are proud to make clinical trials accessbile to our cancer patients. Many of the trials we offer are the very same studies offered at major US cancer centers such as the Mayo Clinic in Minnesota or MD Anderson in Texas. Through partnerships with our oncologists – Rocky Mountain Cancer Centers – and the Colorado Cancer Research Program (CCRP), a non-profit organization founded in 1983 and approved and supported by the National Cancer Institute (NCI), we can connect patients, locally, with close to 100 varied clinical trials. Many of the treatments offered through CCRP have become standard therapies for major forms of cancer, such as breast, colon, leukemia, lung and prostate. As Dr. Eduardo Pajon, Principal Investigator for CCRP likes to say, "Today's cancer treatments were yesterday's clinical trials."
Clinical trials, also known as research studies, test ways to treat people with cancer. The goal of this research is to find better ways to treat cancer and help cancer patients.
Clinical trials test many types of treatment such as new drugs, new approaches to surgery or radiation therapy, new combinations of treatments or new methods such as gene therapy.
A clinical trial is one of the final stages of a long and careful cancer research process. The search for new treatments begins in the laboratory, where scientists first develop and test new ideas.
If an approach seems promising, the next step may be testing a treatment in animals to see how it affects cancer in a living being and whether it has harmful effects. Of course, treatments that work well in the lab or on animals do not always work well in people. Studies are done with cancer patients to find out whether promising treatments are safe and effective.
We encourage you to access the following web sites for more information on Cancer Clinical Trials:
Each clinical trial has an action plan (protocol) that explains how it will work. Each doctor that takes part uses the same protocol.
For patient safety, each protocol must be approved by the organization that sponsors the study, such as the National Cancer Institute, and by the Institutional Review Board (IRB) at each hospital or other study site. The IRB, which includes consumers, clergy and health professionals, reviews the protocol to try to be sure that the research will not expose patients to extreme or unethical risks.
Three Phases of Clinical Trials
Cancer clinical trials include research in three different phases. Each phase answers different questions about the new treatment.
Phase I: trials are the first step in testing a new treatment in humans.
Phase II: trials focus on learning whether the new treatment has an anticancer effect.
Phase III: trials compare the results of people taking the new treatment with the results of people taking standard treatment (e.g., which group has better survival rates? fewer side effects?). In most cases, studies move into Phase III testing only after a treatment shows promise in Phases I and II. Thousands of people around the country may be included in Phase III trials.
Clinical Trials at Boulder Community Health (BCH)
BCH clinical trials are primarily Phase III treatment trials.
Protocols available at BCH include, but are not limited to:
- gastrointestinal (colon)
- genitourinary (bladder, ovarian, uterine)
- head and neck
Existing protocols close frequently and new protocols open frequently.
Questions to Ask
Anyone considering a clinical trial should feel free to ask any questions or bring up any issues concerning the trial at any time.
The following suggestions may give you some ideas as you think about your own questions.
- What is the purpose of the study?
- Why do researchers think the approach may be effective?
- Who has reviewed and approved the study?
- How are study results and the safety of participants being checked?
- How long will the study last?
- What are my responsibilities if I participate?
Possible Risks and Benefits
- What are my possible short term benefits?
- What are my possible long term benefits?
- What are my short term risks, such as side effects?
- What are my possible long term risks?
- What other options do people with my type of cancer have?
- How do the possible risks and benefits of this trial compare with those options?
Participation and Care
- What kinds of therapies, procedures and/or tests will I have during the trial?
- Will they hurt, and if so, for how long?
- How do the tests in the study compare with those I would have outside of the trial?
- Will I be able to take my regular medications while in the clinical trial?
- Where will I have my medical care?
- Who will be in charge of my care?
- How could being in this study affect my daily life?
- Can I talk to other people in the study?
- Will I have to pay for any part of the trial such as tests or the study drug?
- If so, what will the charges likely be?
- What is my health insurance likely to cover?
- Who can help answer any questions from my insurance company or health plan?
- Will there be any travel or childcare costs that I need to consider while I am in the trial?
Tips for Asking Your Doctor About Trials
When you talk with your doctor or members of the research team:
- consider taking a family member or friend along for support and for help in asking questions or recording answers
- plan ahead what to ask—but don’t hesitate to ask any new questions you think of while you’re there
- write down your questions in advance to make sure you remember to ask them all
- write down the answers so that you can review them whenever you want
- consider bringing a tape recorder to make a taped record of what is said, even if you write it down
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