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What are clinical trials?
Clinical trials are research studies that involve people who participate voluntarily. Each study tries to answer specific scientific questions and find better ways to prevent, diagnose, or treat cancer.
Why are cancer clinical trials important?
Cancer clinical trials contribute to medical knowledge and progress against cancer, thus improving patient care. Clinical trials are the only way new cancer treatments can be tested for success and safety before being made available to the public. The standard cancer treatments used today are based on previous clinical trial results.
What are the types of cancer clinical trials?
There are four different types of cancer clinical trials, which include:
- Treatment trials, which test new drugs, medical procedures, or combinations of treatments
- Prevention trials, which look for better ways to prevent diseases by either doing something (called action studies) like making lifestyle changes, or taking something (called agent studies) such as medicines, vitamins, or minerals
- Screening trials, which look for new ways to test for the presence of a disease or health condition early, when it may be more easily treated
- Quality of life trials, which explore ways to improve comfort and quality of life for cancer patients
What is a protocol?
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to protect the health of the participants as well as answer specific research questions. A protocol specifically outlines the purpose of the study as well as details such as who is eligible to participate, the study size, number of participants and describes the plan of care and collection of data. A study’s protocol is carefully developed and reviewed by the Principal Investigator and the sponsoring organization. It is then reviewed and approved by an Institutional Review Board (IRB) to ensure trial procedures are consistently carried out. This protocol is used by every doctor taking part in the study.
Why consider a clinical trial for your cancer treatment?
Those who do decide to participate can experience benefits, which may include:
- Access to a cancer treatment that isn’t yet publicly available
- Free or low-cost treatment for the duration of the study
- Contributing to cancer research that may provide life-saving treatment to future cancer patients
- A more active role in your own healthcare
- Close monitoring from some of the best cancer doctors
What are some possible risk of participating in clinical trials?
Some possible risks that patients may face could include:
- Participants in randomized studies will not be able to choose the treatment approach they receive
- Therapies under study are not always better than the standard care
- New treatments may have unknown side effects or risks
Since risks vary in each individual situation, it’s important to talk with your oncologist to understand the specific risks related to any clinical trial that you may be considering participation in.
How are my right protected during a clinical trial?
Clinical trials are conducted according to strict scientific and ethical principles, and groups of experts at the national and local levels approve research studies before they begin. One important group who evaluates clinical trials is the Institutional Review Board (IRB) of the research organization implementing the trial. An IRB is made up of doctors, researchers, community leaders and other members of the community. This board is focused on protecting the safety of participants by reviewing the protocol to make sure the study is conducted fairly and participants are well-informed of their rights during the study.
Who pays for clinical trials?
There are two types of costs associated with a clinical trial: patient care costs and research costs.
- Patient care costs are those costs related to treating your cancer, whether you are in a trial or receiving standard therapy. These costs are often covered by health insurance and usual copays and coinsurance would apply. Doctor visits, hospital stays, standard cancer treatment, lab tests, and imaging tests are considered patient care costs.
- Research costs are those related to taking part in the trial. Often these costs are not covered by health insurance, but are usually covered by the research trial’s sponsor. Study drugs as well as additional lab or imaging tests performed solely for the trial are examples of research costs.
When you take part in a clinical trial, you may have extra doctor visits that you would not have with standard treatment. During these visits your doctor carefully watches for side effects and your safety in the study. These extra visits can add costs for transportation and child care.
Will I continue to work my with my primary healthcare provider while in a research trial?
Yes. Most clinical trials do not provide complete primary healthcare.
Do I have to participate in a clinical trial?
No. Your participation in a clinical trial is completely voluntary at all times. Cancer patients considering participation must first learn the key facts such as the purpose, risks, and benefits of the specific clinical trial. This process is called informed consent. It is important to ask lots of questions and consider all of your treatment options before you decide if taking part in a study is right for you.
How should I prepare for the meeting with the research coordinator or doctor?
There is a lot to learn regarding clinical trials. To ensure that you gather all the necessary information, come prepared with a list of possible questions to ask. Additionally, consider asking a friend or relative to join you for support and to hear the responses to the questions.
Can I leave a clinical trial after it has begun?
Yes. Cancer research participation is strictly voluntary. Participants may withdraw their decision to participate at any time for any reason. When withdrawing from the clinical trial, you should let the research team know about it and the reasons for leaving the study.
What if the new treatment does not seem to be working for me?
With clinical trials, it is important to remember that the new cancer treatment may not be better than, or even as good as, the standard treatment. After a Phase I or II trial, the researchers decide whether to move on to the next phase or to stop testing the treatment or procedure because it was unsafe or not effective. If the cancer treatment you are receiving doesn’t seem to be working, you should discuss with your oncologist to consider other cancer treatment options.
What do I do if I want to consider a clinical trial for my cancer treatment?
If you are interested in clinical trial participation, you should know as much as possible about the study. This means taking time to ask important questions regarding the study, including its purpose, the procedures involved, and expenses you’ll be faced with.
Do I have to go to a different oncologist if I participate in the trial?
No. Typically, patients who decide to participate in a clinical trial keep their current oncologist since clinical trials do not provide extended or complete healthcare. Maintaining a relationship with your doctor helps ensure that the study protocol will not conflict with other medications or treatments that you are receiving.