Clinical Trials FAQs

What are clinical trials?

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.

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:

  1. Treatment trials, which test new drugs, medical procedures, or combinations of treatments
  2. 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
  3. 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
  4. Quality of life trials, which explore ways to improve comfort and quality of life for cancer patients

How are cancer clinical trials conducted?

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.

What are the benefits of participating in a clinical trial?

  • You may have access to promising new therapies that doctors hope will be more effective or less toxic than the standard treatment. These therapies are not yet available to patients outside the study.
  • You can play an active role in your cancer care by expanding your treatment options.
  • You will receive expert medical care during the trial and throughout your treatment.
  • Your overall health is closely monitored throughout the trial.
  • You will be contributing to greater knowledge that may help other cancer patients in the future.

What are some of the possible risks of participating in a clinical trial?

  • Participants in randomized studies will not be able to choose the approach they receive.
  • Health insurance and managed care providers may not cover all patient care costs in a study, in which case the patient would be responsible for those costs.
  • Therapies under study are not always better than the standard care.
  • New treatments may have unknown side effects or risks.

How are my rights protected during a clinical trial?

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.

Who pays for clinical trials?

There are two types of costs associated with a clinical trial: patient care costs and research costs.

  1. 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.
  2. 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 with my primary healthcare provider while in a research trial?

Yes. Most clinical trials do not provide complete primary health care. 

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.

When considering if I want to participate in a study, what type of information will be available?

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.

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. 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.  

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 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.

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.

Your Doctor Can Tell You More

If you have any questions about how clinical trials work, please ask your doctor, nurse or other healthcare professional. 

 

Sources: