CMOH offers clinical trials through US Oncology Research, one of the largest community-based research programs in the U.S., with over 60 research sites. US Oncology Research has enrolled over 80,000 patients in clinical trials and played a role in nearly 100 FDA-approved cancer therapies.
Clinical trials are research studies that involve people who participate voluntarily. Each study that CMOH participates in tries to answer specific scientific questions and find better ways to prevent, diagnose, or treat cancer.
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.
Clinical trials are a critical component in expanding treatment options for people with all types of cancer. Because all new therapies must be evaluated through clinical trials, the greater the number of people who participate, the faster emerging anticancer therapies can be brought to patients. Clinical trials are also important because they offer hope to people with cancer by providing access to promising new therapies not yet available outside the study.
There are four different types of cancer clinical trials, which include:
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.
Clinical trials are designed by cancer doctors and researchers, and they are conducted according to strict scientific and ethical principles. Before a cancer research study begins, a protocol is developed describing what will be done in the study, how it will be conducted and why each part of the study is necessary. This research protocol is reviewed by third-party experts to make sure that study is conducted fairly and that patients are well-informed of their rights. Each study has eligibility criteria regarding who can or cannot participate in the study, which may include the type of cancer, age, gender, medical history, and current health status.
Patients considering participation in a clinical trial will receive important facts about the study’s purpose and what is involved, such as the tests and other procedures used, and the possible risks and benefits of clinical trials. Should a patient decide to participate, he or she will be asked to sign a written consent form that outlines the details of the study prior to beginning the clinical trial. However, participation in the trial is completely voluntary and patients may stop at any time.
Those who do decide to participate can experience benefits, which may include:
Some possible clinical trial risks that patients may face could include:
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.
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.
There are two types of costs associated with a clinical trial: patient care costs and 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 cancer care team carefully watches for side effects and your safety in the study.
Yes, most clinical trials do not provide complete primary health care.
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.
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. You might also want to bring a device that can record the discussion. Additionally, consider asking a friend or relative to join you for support and to hear the responses to the questions.
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.
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.
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. Other questions to ask about cancer research include:
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.