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Clinical Trials & Studies

Choosing to participate in a Clinical Trial or Study is a very personal decision – and something you and your entire Moffitt care team can decide together.

Clinical Trials and Studies

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Clinical Trials: Are They Right for You?  Researchers across the country are working every day to find new and better ways to treat cancer and improve the health of patients like you. Clinical trials are studies that look at new treatments to fight cancer. For example, clinical trials might involve testing new drugs. They may also involve finding better ways to do cancer surgery or give radiation therapy. All of today’s most effective cancer treatments are based on the results of past clinical trials. If your doctor thinks you may benefit he or she may suggest that you take part in a clinical trial to treat your cancer.

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Will I be a guinea pig?
The fear of being a guinea pig is a common concern among patients. Many patients fear that they might be tested or experimented on without their best interests in mind. In fact, this is not the case. Clinical trials are carefully designed studios that put the health and safety of the patient first.

Are clinical trials only for patients who have no other treatment options?
No. Clinical trials can be for patients who are just starting cancer treatment as well as patients who have been receiving cancer treatment for some time.

Are clinical trials available for all types of cancer?
No. Some patients may find their doctor has no clinical trial currently available for their disease. Also, even if there is a clinical trial available, patients may still find they are not eligible to be in a trial because of factors such as their health condition, stage of cancer, other health problems, or past cancer treatments. Your doctor can tell you more.

Will I be given a placebo on a clinical trial?
Another concern of some patients is that they will get a placebo. A placebo is a look-alike pill or treatment that contains no medicine. When no standard treatment exists for a cancer, some studies compare a new treatment with a placebo. But placebos are rarely used in cancer treatment trials. If there is a placebo, you will be told ahead of time and your doctor will discuss this with you.

What can I expect if I take part in a clinical trial?
To help you make an informed decision the doctor will sit with you and discuss what the treatment is, what is going to happen, and what your care will be like. This is a good time to discuss with your doctor how the study may affect you and your everyday life.

What is expected of you in a clinical trial is written into an informed consent form. Informed consent means that you must be given all of the facts about a study before you decide whether or not to take part.
Taking part in a study may require more of your time. This is because you may have more tests and doctor visits than if you were not in the study. But many patients feel the quality of care and attention they get is worth the extra time.

Are there extra costs when you take part in a clinical trial?
In most cases, when a study is developed, researchers try to find ways to pay for the trial. If any tests planned are not standard care, then the clinical trial would pay for those added tests. Also, many insurance companies cover the cost of clinical trials. To find out in advance what costs would be paid in your case, talk to a doctor, nurse or social worker from the study. Also, the consent form will state if there are extra costs.

How are new cancer treatments developed?
The search for new treatments begins in the laboratory. If a treatment looks promising, it is then tested in humans. When this happens, it goes through three phases of testing. At each phase, different research questions are asked. Keep in mind that a clinical trial is one of the final stages of a long and careful research process.

What are the three phases of clinical trials?
Phase 1 Trials

  • Look for the best way to give a new treatment
  • Learn how a new treatment can be given in the safest way
  • Enroll a small number of patients

Phase 2 Trials

  • Find out how the new treatment affects the cancer (Does it shrink the tumor?)
  • Enroll a small number of patients

Phase 3 Trials

  • Test treatments that have shown promise in Phase 1 or 2 trials
  • Enroll hundreds of patients

How am I protected if I take part in a clinical trial?
It is important to know the development of a new cancer treatment goes through many steps that are part of the research plan. The research plan, often referred to as a protocol, carefully outlines what the study will do, how it will be done, and why it is done. This plan is designed to protect the safety of those who take part in the study. The plan must follow strict guidelines that are monitored by a board called the Institutional Review Board (IRB). The main job of the IRB is to protect the health, safety, and well-being of patients in research.

Can I say no to a clinical trial?
It is okay to say no to a clinical trial. In fact, you can change your mind even after the study starts. Signing a consent form does not mean you must stay in a clinical trial. If you choose to leave the study, you will have the chance to discuss other treatments and care with your doctor.

What should I ask my doctor?
Ask your doctor if there is a clinical trial for you. And if there is, be prepared to ask more questions so you can figure out if taking part in a clinical trial is right for you. If you have trouble coming up with questions, think about how being in a study might affect your everyday life.

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