The decision to participate in a clinical trial is personal and factors depend on each individual patient. If you decide to participate in a clinical trial at Moffitt, our team is here to support you and your family every step of the way. Here are some frequently asked questions and answers about clinical trials:
To help you make an informed decision the doctor will discuss with you what the treatment is, what is going to happen, and what your care will be like. This is a good time to discuss how the study may affect you and your everyday life with your doctor. 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.
Another thing 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.
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.
No. Some patients may find their doctor has no clinical trial currently available for their disease. Also, even if 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.
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.
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
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.
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 studies that put the health and safety of the patient first.
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.
As with most drugs, undesirable side effects cannot be ruled out. The "Risks" section of our informed consent document is your to-go source for potential side effects, the likelihood they will occur and how to talk to your healthcare team.
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.
If you decide to participate in a clinical trial, our social work staff can help you with a wide variety of social, logistical and financial issues that may arise.
Diversity is important because oftentimes drugs behave differently from one population to another. Failing to understand these differences at the clinical trial stage could leave future patients at risk. At Moffitt, we are committed to diversity in patient access to care and research.
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.
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.
To learn more about a clinical trial, call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form online.