Please read the frequently asked questions which provide introductory information about clinical trials. In addition, it is often helpful to talk to a physician, family members, or friends about deciding to join a trial.

Below are questions that are frequently asked regarding a clinical trials program.

• What are clinical trials?
• What are the benefits to taking part in a clinical trial?
• How do clinical trials work?
• What clinical trial safeguards are in place?
• What is giving consent to participate in a clinical trial?
• What other concerns should I have?
• What about confidentiality?
• Who pays for the clinical trial?
• Where is treatment given?
• What questions should you ask?
  

A clinical trial is a research study designed to evaluate potential, new treatment options. These studies are the result of a long and deliberate cancer research process that often takes years. Clinical trials test the safety and effectiveness of new or modified cancer drugs, new drug doses, unique approaches to surgery or radiation therapy, and varied combinations of treatments.

For some people, a clinical trial implies experimentation or being a guinea pig. However, as with any fear of the unknown, understanding the process can ease your anxieties and equip you with the knowledge you need to make an informed decision about whether to participate in a clinical trial.

Patients who participate in a clinical trial receive either a promising new treatment being tested or the best available conventional treatment. And, while there is no guarantee that any treatment will be successful, prior clinical trials have proved to be some of the most effective treatments currently in use for cancer today.

What are the benefits to taking part in a clinical trial?

Most patients choose to participate in a clinical trial with a desire of finding a better treatment or cure. While there are no guarantees, researchers hope that the treatment options offered through clinical trials will be comparable or better than current standard care. If a new treatment option is proven to work, and you are participating in the clinical trial, you will be among the first to benefit.
Other benefits include:

• Access to state-of-the-art treatment for certain types of cancer
• Dedicated attention from a research nurse who attends all treatment, follow-up and care associated with the clinical trial in the physician’s office
• Direct contribution to finding better ways to prevent, detect or treat cancer

How do clinical trials work?

Clinical trials are designed to test treatments under very specific scientific and ethical guidelines. Each study follows a precise action plan (protocol) that explains the number of people that will participate in the study, who is eligible to participate, what study drugs participants will take, what medical tests will be administered and how often, and what information will be gathered. The Florida Hospital Cancer Institute (FHCI) uses the same research protocol as all other research centers participating in a particular study.

Clinical trials are conducted in the physician’s office and occasionally in the hospital. When the physician has identified a clinical trial as an appropriate treatment option, a Clinical Research Center registered nurse is notified to determine the patient’s eligibility for the trial. The specific type or stage of cancer usually determines eligibility, as well as other factors.

Once eligibility is established, the research nurse will explain the informed consent process. Informed consent is one of the patient’s most important rights in the research process, as it outlines the purpose of the study, the exact treatments that will be administered, all possible side effects, and the patient’s right to withdraw from the study at any point. Signing the consent form acknowledges that the trial was explained and is understood.

What clinical trial safeguards are in place?

Both standard care and clinical trials have risks, side effects and benefits that vary depending on the individual. However, there are rigorous guidelines in place to protect the well-being and safety of clinical trial participants. The physician and research nurse conducting the study will explain any known or anticipated risks ahead of time. This information is contained in the informed consent form as well. Also, clinical trial participants are monitored closely to identify any changes in their condition.

What is giving consent to participate in a clinical trial?

Because every clinical trial is designed to answer a specific research question, each clinical trial can only enroll patients with certain types and stages of cancer. Your overall health may also be a factor in whether you are an appropriate candidate for a particular clinical trial.

The procedures that help us determine if a specific patient volunteer is appropriate for a particular clinical trial also provides the patient with information to help them decide whether they wish to volunteer for the clinical trial. Your medical records are examined, and your study physician reviews them with you to obtain an appropriate medical history. You will also have a physical exam and possibly other tests such as blood work, x-rays, and other types of scans. The clinical trial team then reviews your medical history and the results of your exams and tests. From this, they decide if you are an appropriate candidate for the clinical trial, meeting all necessary criteria.

If you are not found to be eligible for a specific clinical trial, you should not necessarily feel that there is anything wrong with you. This only means that you do not meet all the specific requirements for that particular clinical trial. In many cases, patients do not qualify for clinical trials because they are actually too healthy, or their disease is not advanced enough.

If you are found to be eligible and meet all of the criteria, the clinical trial team will then discuss with you and your family the purpose of the clinical trial and what it involves. They will explain the experimental plan that must be followed carefully and any approved treatments available to you.

You will receive a consent form that must be signed before you enter or start the trial. Before you sign the consent form, you should review the form and discuss it with your family and friends. It is important that you write down any questions that you have and discuss them with your study doctor or nurse before you sign it, keeping in mind that your signature does not relinquish your right to discontinue participation in the clinical trial at any time you wish. After you have signed the consent form, you will be given a copy for your reference.

The consent form contains information about the experimental treatment, known side effects and risks, possible benefits, potential costs and payments, and alternative treatments. The consent form will also include information about whether you will need to be hospitalized specifically for the clinical trial, how long the trial lasts, the frequency of study visits, and other important issues.

Participation in a clinical trial is completely voluntary. It is your decision. You may decide to stop participation at any time during the clinical trial. All clinical trial personnel will support whatever choice you make. Choosing not to participate in or withdrawing from a clinical trial will not affect your ability to receive regular treatment.

Making a decision to participate in a clinical trial takes time and careful consideration. It requires a commitment from you and your family or friends to help ensure that you have been properly informed of all information.

What other concerns should I have?

It is not unusual to have some fears or concerns about participating in a clinical trial. Many patients worry that they will become a “guinea pig” or “just another subject number”. Patients in clinical trials receive the same level of care from doctors and nurses as patients not participating in clinical trials. However, patients on clinical trials are often more closely monitored and may undergo more frequent testing and exams to help evaluate the progress of their health and their disease. Patients regularly receive information about their condition and test results from their study doctor and nurse. They continually learn about their disease, its treatment, and ways to help themselves.

Patients in our clinical trials are monitored by nurses who are the clinical coordinators for the trials. They ensure that the clinical trial tests and examinations are scheduled and completed, and that the test results and any side effects are documented. They can discuss all aspects of the study with you before, during, and even after the trial. The clinical coordinator works closely with all other clinical trial personnel to plan your care and procedures, and will probably provide you with a calendar so that you can remember when you are scheduled for study visits and tests. If you are giving yourself medications at home that are part of the clinical trial, you may also be given a diary card on which to record these medications and any side effects that may occur.

Finally, patients with cancer and their families and friends often have mixed emotions. They may feel anger, sadness, fear of the future, nervousness, etc. Oncology nurses, doctors, psychologists, and social workers understand this. They can help give you and your family emotional support before, during, and after the clinical trial.

What about confidentiality?

Information that is learned about any individual participating in a clinical trial is confidential. Specific study sponsors (e.g., research institutions, universities, or pharmaceutical companies) and monitors from those sponsors may review your medical records to ensure that clinical trial guidelines are being followed. Any information that is reported to the sponsor about your case will not identify you by name. Generally, only the results of the whole group of patients on the clinical trial are reported. The results of the clinical trial, however, will be shared with health care professionals and other researchers so that the findings can be used to help treat other people with cancer or advance additional research efforts.

Who pays for the clinical trial?

Most treatment received in a clinical trial is considered normal standard of care. Not all health insurance and managed care providers cover all patient care costs in a study. However, non-FDA-approved drugs used in clinical trials and extra tests which would not normally be done, are provided at no cost to study participants.

Where is treatment given?

Patients enrolled in clinical trials may receive their experimental treatment in:

• a Clinical Research Unit
  
• a department in a hospital or cancer center
  
• a doctor's office
  
• a combination of these locations

Care is provided by oncologists and oncology nurses. Certain procedures of some clinical trials also may be carried out by the doctor who referred you.

What questions should you ask?

Your health care team wants to make certain that you have all the information you need before and during your participation in a clinical trial. Please share your questions or concerns with your doctor and nurse. You may even wish to print and take this list of questions with you to your next appointment.

The Study

• What is the purpose of the study? In what phase is this research study?
  
• Who sponsors the study, and who has reviewed and approved it?
  
• How is the study data and patient safety being checked?
  
• When and where will study results and information go?

Possible Risks and Benefits

• What are the possible short- and long-term risks, and side effects?
  
• What are the possible benefits to me?
  
• Are there standard treatments for my type of cancer?
  
• How do the possible risks, side effects, and benefits in the study compare with standard treatment?

Your Care

• What kinds of experimental treatments, medical tests, or procedures will I have during the study? Will they be painful? How do they compare with what I would receive outside the study?
  
• How often and for how long will I receive the experimental treatment, and how long will I need to remain in the study? Will there be follow-up after the study?
  
• Where will all procedures take place? Will I have to be in the hospital? If so, how often and for how long? Can a family member or friend stay with me during study visits?
  
• How will I know if the experimental treatment is working?
  
• Will I be able to see my own doctor? Who will be in charge of my care?

Personal Issues

• How could the study affect my daily life?
  
• Can you put me in touch with other people who are in this study?
  
• What support is there for me and my family in the community?
  

Cost Issues

• Will I have to pay for any of the experimental treatment, tests, or other charges?
  
• What is my health insurance likely to cover?
  
• Who can help answer any question from my insurance company or managed care plan?
  

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