Clinical trials are research studies conducted with people who volunteer to participate in the testing of new therapies. The purpose of these studies is to find better therapies for cancer treatment.
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.
There are four different types of cancer clinical trials, which include:
Clinical research trials are designed by physicians and researchers who develop an action plan (protocol) that describes what will be done in the study, how it will be conducted and why each part of the study is necessary. Each study has eligibility criteria for who can or cannot participate in the study, which may include type of cancer, age, gender, medical history and current health status. This protocol is used by every doctor taking part in the study.
Clinical research 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 doctor carefully watches for side effects and your safety in the study. These extra visits can add costs for transportation and child care.
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.
A doctor, nurse or someone from the Compass Oncology research team will give you the important facts about the study, including the purpose of the study and what is involved such as the tests and other procedures used, possible risks and benefits. You will also receive a written consent form explaining the study, which you will be asked to sign should you decide to participate. However, even if you sign the consent form, you may stop participating in the study at any time.
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 clinical 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.
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.
If you have any questions about how clinical trials work, please ask your doctor, nurse, or other healthcare professional.