Participating in a Clinical Trial
We have approximately 150 cancer clinical trials underway at any given time.Why are clinical trials important?
Clinical trials have provided marked advances in cure, life extension, care, quality of life and prevention. Personalized care is becoming a reality to fit the specific care to the unique patient at the specific time. For example, a lung cancer trial examines all of the genes related to the cancer in hope of finding a unique gene change that can be attacked by new cancer drugs.What kinds of cancer clinical trials are offered via the UH Cancer Center?
The Center provides national cooperative clinical trials through a National Cancer Institute (NCI) Community Oncology Research Program. The Program is funded by the NCI. Taking part in the Program has given people in Hawai'i, including those in underserved and minority populations, access to the best standard treatment and an opportunity for improved care.
The Center also conducts pharmaceutical-sponsored and investigator-initiated clinical trials. The trials are conducted at various clinical sites in our community. Innovative investigational new drugs under development are investigated in cancer types common to the local population.Does participating in a study mean I will receive either the experimental treatment, or a placebo?
This is dependent on the specific study and should be discussed with the treating physician. Each clinical trial has an action plan (protocol) that explains how it will work. Each study enrolls people who are alike in key ways.Cancer clinical trials include research at three different phases:
- Phase I trials are the first step in testing a new treatment in humans. In these studies, researchers try to find the best dose to give a new treatment. They also try to find out if and how the treatment can be given safely and they watch for any harmful side effects.
- Phase II trials focus on learning whether the new treatment has an anticancer effect.
- Phase III trials compare a new treatment to one or more other treatments. In Phase III trials, people are assigned at random to receive either the new treatment or the standard treatment.
It depends on the type of clinical trial. But it's true that most trial participants see their doctors more often, and have more blood draws, imaging scans and other tests than cancer patients on conventional treatment. The additional monitoring is important, because it protects the safety of patients enrolled in the study and shows whether the experimental treatment is working.How can I be sure I get the experimental drug when I participate in a clinical study?
You can't. The purpose of a clinical trial is to find out whether an experimental drug works better than conventional treatment. To ensure valid results, most clinical trials are blinded so neither you nor your doctor will know which type of medicine you receive.What if I decide I want out of the study?
You have the legal right to withdraw from a clinical trial at any time for any reason. If you decide to withdraw, you will continue to be treated at your clinic site with the best conventional therapies available for your type of cancer.Who pays for a clinical trial?
Clinical trials are sponsored by federal agencies like the National Institutes of Health or by private pharmaceutical or biotechnology firms. The costs of the clinical trial and the experimental therapy are covered by the sponsor. You and your insurance company are responsible for the cost of tests and procedures that are part of standard medical care. Before enrolling in a clinical trial, it is important to know exactly what will be covered by the trial's sponsor. Ask the doctor or nurse-practitioner in charge of the trial and check with your insurance company before you agree to volunteer.What factors affect whether a health insurance plan will pay for participation in a clinical trial?
Health insurance companies and managed care companies decide which health care services they will pay for by developing a coverage policy regarding the specific services. In general, the most important factor determining whether something is covered is a health plan's judgment as to whether the service is established or investigational. Health plans usually designate a service as established if there is a certain amount of scientific data to show that it is safe and effective. If the health plan does not think that such data exist in sufficient quantity, the plan may label the service as investigational.
Health care services delivered within the setting of a clinical trial are very often categorized as investigational and not covered. This is because the health plan thinks that the major reason to perform the clinical trial is that there is not enough data to establish the safety and effectiveness of the service being studied. Thus, for some health plans, any mention of the fact that the patient is involved in a clinical trial results in a denial of payment.If I join a clinical trial, will I have to stop seeing my community oncologist?
If you volunteer for a clinical trial, your clinical care must be provided by University of Hawaii Cancer Center doctor who is responsible for patients enrolled in the trial or by their associates. Chances are, your doctor is a UH Cancer Center doctor. If, however, you are traveling to Oahu to be seen, then we may be able to arrange for routine tests to be performed by your community doctor.Will I get paid for being a study volunteer?
That depends on the study's sponsor. Some clinical trials reimburse study volunteers for expenses involved in traveling to Oahu, especially if it requires an overnight visit. Some studies offer a small stipend for the time and inconvenience involved in participating in the study. But many clinical studies provide no reimbursement for study participants.If I join a clinical trial, what's in it for me?
No one can promise that an experimental treatment will cure your cancer, but it may prolong your life and give you more quality time to spend with your family and friends. Even if you don't receive any direct personal benefit, you will have the satisfaction of knowing that you've made an invaluable contribution to research. Many cancer patients who volunteer for clinical trials say they do it to help their children, grandchildren and others who may be diagnosed with cancer in the future.What kind of information will I get if I want to take part in a trial?
Before you join, a person on the research team will explain why the study is being done, and what will happen during the study. You can ask any questions you have about the study. You will also be given a consent form to read. This form will explain:
- The plan for each step in the study
- Possible side effects
- How the study may affect your daily life
You should ask questions about any part of the consent form you do not understand. If you decide to take part in the study, you will be asked to sign the consent form. Even if you sign the form, you can still change your mind and withdraw from the study at any time.Where can I find information about University of Hawaii Cancer Center clinical trials?
Start by asking your primary care doctor or oncologist about University of Hawaii Cancer Center clinical trials for your type of cancer. There are many sources of information about clinical trials on the Internet:
- The University of Hawaii Cancer Center website, uhcancercenter.org, includes a list of University of Hawaii Cancer Center clinical trials for many diseases and conditions. For more information, follow this link directly: http://oncore.cc.hawaii.edu/sip-mobile/sip.html.
- A federally funded website, clinicaltrials.gov, includes a list of clinical trials in Hawaii as well as the other 49 states.