The following are common questions people have about participating in clinical trials:

• Who should consider clinical trials and why?
• How do we enroll people in clinical studies?
• What are the potential risks and benefits of clinical trials?
• What is informed consent?
• Could I receive a placebo?
• What happens during a trial?

Who should consider clinical trials and why?

The treatment you receive during a clinical trial may help you. Clinical trial participants receive either the most effective known treatment available; the new drug or treatment being considered or a combination of the two options.

It is important to test drugs and medical products in the people they are meant to help. Conducting research in a variety of different ages, races, ethnic groups, and genders of people is important because people may respond differently to treatments.

Some people participate in clinical trials because they have exhausted standard treatment options. The treatments either did not work for them, or they were unable to tolerate certain side effects. Clinical trials may provide another option when standard therapy has failed.

Other people participate in trials because the want to contribute to the advancement of medical knowledge, which will help other people in the future.
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How do we enroll people in clinical studies?

Clinical trials usually evaluate very specific new treatments for very specific conditions. Therefore, they have strict criteria about who is and who is not a candidate for each study. To ensure you have the broadest possible range of treatment options available, our research nurses will review your case during the diagnosis stage to see if you may match any of the criteria for the clinical trials in which PAMF is participating.

If you are eligible for a current study, a research nurse will provide the details of the study to your oncologist, who will then ask you if you would be interested in learning more about participating in the clinical trial. Participating in a clinical trial may require some extra time on your part. The research team will want to monitor you closely during the trial and collect follow-up information. This care may be in addition to the care you will continue to receive from your oncologist and medical team.

If you are interested in a clinical trial, here are the steps you will need to take to enroll in the study:

1. Receive a packet of information on the study from your oncologist to take home and review. Informed consent is critical for a good clinical trial, so even if you are sure that you would like to do the study, you must take the information home and review it before you can sign up. The packet, which is called an informed consent form, will include answers to the following questions:
   • What is the purpose of the clinical trial?
     
   • How long will the trial last?
     
   • What is required of you to participate in this trial?
     
   • What treatments or drugs will you receive during the trial?
     
   • What treatments, tests and/or procedures will be required during the trial? How many and how often?
     
   • Which treatments, tests, medications and/or procedures will be paid for?
     
   • What are the risks and benefits of participating in the study?
     
   • What options are available for you if you do not participate in the trial?
2. Meet with the research nurse who will review the contents of the informed consent with you again and show you the forms that you need to sign.
   
3. If you decide to participate, you will be registered to the trial and your treatment will be determined by the protocol. In most cases, some patients will receive standard treatment, some patients will have the investigational treatment, and some will have a combination or variation of both. In some cases, patients may receive a placebo, but only if they have already been treated or will be treated adequately for their disease.

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What are the potential risks and benefits of clinical trials?

Potential benefits include:

• Health care provided by leading physicians in the field of cancer research
  
• Access to new drugs and interventions before they are widely available
  
• Close monitoring of your health care and any side effects
  
• A more active role in your own health care
  
• An opportunity to be among the first to benefit from the new approach being studied, if it is found to be helpful
  
• A chance to make a valuable contribution to cancer research
  Potential risks include
  
• New drugs and procedures may have side effects or risks unknown to the doctors
  
• New drugs and procedures may be ineffective, or less effective, than current approaches
  
• Even if a new approach has benefits, it may not work for you

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What is informed consent?

Before a patient decides to participate in a study, researchers are required to inform patients about the study's treatments and tests, and their possible benefits and risks. This process is called informed consent.

Informed consent is a process in which you learn the key facts about a clinical trial before you decide whether or not to participate. Your research nurse or doctor will discuss these facts with you, and then include them in a written consent form that you can take home to read and discuss. The consent form will include details about the study approach, the intervention given in the trial, the possible risks and benefits, and the tests you may have.

Don't hesitate to ask questions to ensure you have all the information you need. While informed consent begins before you agree to participate in a trial, you should feel free to ask the health-care team any questions you have at any point. Informed consent continues as long as you are in the study. You can change your mind and leave the study whenever you want -- before the study starts or at any time during the study or follow-up period.
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Could I receive a placebo?

A placebo is an inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested in a clinical trial. In treatment trials involving people who have cancer, placebos are rarely used.

Many treatment trials are designed to compare a new treatment with a standard treatment, which is the best treatment currently known for a cancer based on results of past research. In these studies, patients are randomly assigned to one group or another. When no standard treatment exists for a cancer, a study may compare a new treatment with a placebo. However, you will be told about this possibility during informed consent, before you decide whether or not to take part in the study.
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What happens during a trial?

If you decide to participate in a clinical trial, you will work with a research team. Team members may include doctors, nurses, social workers, dieticians and other health care professionals. They will provide your care, monitor your health carefully, and give you specific instructions about the study.

Participating in a trial may mean that you might have more tests and doctor visits than you would if you weren't in the study. Team members also may continue to stay in contact with you after the trial ends. To make the trial results as reliable as possible, participants must follow the research team's instructions. That means having all doctor visits and tests, taking medicines on time, and completing logs or answering questionnaires.
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