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Participating in a Trial: Questions to Ask Your Doctor

Ten Things to Know About Cancer Treatment Trials

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Are Clinical Trials for You?
Information for people who would like to know more about participating in clinical trials.

What are clinical trials?
Clinical trials are research studies conducted with people who volunteer to participate.  These people are referred to as participants, volunteers, or subjects.  Each study is designed to learn better ways to prevent, diagnose or treat a disease. 

What types of clinical trials are there?
There are different types of clinical trials depending on what the doctors are trying to learn:

  • Prevention trials study ways to reduce risks of developing a disease.
  • Screening trials study ways to detect the disease before symptoms occur.
  • Diagnostic trials study ways to identify the disease earlier and more accurately.
  • Treatment trials study ways to improve comfort and quality of life.
  • Supportive care or quality of life trials study ways to improve comfort and quality of life for patients with that disease.
  • Genetic trials study how the body’s genes can affect diagnosis and response to treatment.

Where do clinical trials come from?
Clinical Trials are sponsored by government agencies, by cooperative groups of hospitals or doctors, by commercial companies testing new drugs or medical devices, or by individual doctors and hospitals.

How are you protected?
Participants in clinical trials are protected by strict ethical, scientific and regulatory requirements for conducting research in people.  The AAMC Research Institute has an Institutional Review Board (IRB) which must approve a research study before it is offered to participants.  The IRB members include community representatives, clergy and healthcare professionals.  The IRB monitors the clinical trials while they are being conducted to ensure that the studies are safe and risks to participants are minimized.  Participation is voluntary and participants have the right to leave a study at any time.  Any questions or concerns about participating in research can be directed to the Research Integrity Officer by calling 443-481-1320.

Who participates in clinical trials?
Not everyone is eligible to participate in a clinical trial.  Studies have strict criteria about who can be included in a study.  So even if you decide to participate, you may not be enrolled in a clinical trial. 

What happens if you decide to participate?
People considering participation in a clinical trial receive detailed information about the study from their doctor, nurse, and other people involved with the trials.  There is a thorough process called “informed consent” to explain what will happen during the trial, risks and benefits, and your other options.  If you decide to participate, you will be asked to sign a consent form.  Participants are encouraged to ask questions; discuss participation with family, friends, or your primary care provider; and carefully consider the decision to participate in a clinical trial.  Once you agree to participate, you will be evaluated to decide if you are eligible to participate in the study.  If you are eligible, you will be enrolled in the study.  In addition to your routine health care, you may be asked to come in for additional tests, exams, or procedures, or to fill out questionnaires.  If you are not eligible, then you cannot be enrolled in the study.  At Anne Arundel Medical Center, patients receive the same high quality care, whether or not they decide to participate in a clinical trial.

What are the benefits of participating?
Benefits of participating in a clinical trial may include:

  • The possibility of access to promising new treatment approaches that may not be available outside the clinical trials setting.
  • The satisfaction of knowing that the results of the study may help others in the future.

What are the risks of participating?
Risks of participating in a clinical trial may include:

  • What is being studied may not be as good as standard care.
  • Unexpected side effects or worse side effects.
  • You may not be able to choose the treatment you will get.
  • Health insurance may not cover all the costs.
  • More visits, tests, and exams than if you were not participating in the clinical trial.

 

How do you participate?
The staff of the AAMC Institute will work with you and your doctor to determine if there is a clinical trial that is right for you.  You can contact the Research Institute at (443) 481-1320.

You may also find more information on the internet at: 
http://www.aahs.org
http://www.clinicaltrials.gov  
http://www.cancer.gov/clinicaltrials

 

Participating in a Trial:  Questions to Ask Your Doctor

Anyone considering a clinical trial should feel free to ask any questions or bring up any issues concerning the trial at any time.  The following suggestions may give you some ideas as you think about your own questions.
The Study

  1. What is the purpose of the study?
  2. Why do researchers think the approach may be effective?
  3. Who will sponsor the study?
  4. Who has reviewed and approved the study?
  5. How are study results and safety of participants being checked?
  6. How long will the study last?
  7. What will my responsibilities be if I participate?

Possible Risks and Benefits

  1. What are my possible short-term benefits?
  2. What are my possible long-term benefits?
  3. What are my short-term risks, such as side effects?
  4. What are my possible long-term risks?
  5. What other options do people with my risk of cancer or type of cancer have?
  6. How do the possible risks and benefits of this trial compare with those options?

Participation and Care

  1. What kinds of therapies, procedures and /or tests will I have during the trial?
  2. Will they hurt, and if so, for how long?
  3. How do the tests in the study compare with those I would have outside of the trial?
  4. Will I be able to take my regular medications while in the clinical trial?
  5. Where will I have my medical care?
  6. Who will be in charge of my care?

Personal Issues

  1. How could being in this study affect my daily life?
  2. Can I talk to other people in the study?

Cost Issues

  1. Will I have to pay for any part of the trial such as tests or the study drug?
  2. If so, what will the charges likely be?
  3. What is my health insurance likely to cover?
  4. Who can help answer any questions from my insurance company or health plan?
  5. Will there be any travel or child care costs that I need to consider while I am in the trial?

Tips for Asking your Doctor about Trials

  1. Consider taking a family member or friend along for support and for help in asking questions or recording answers.
  2. Plan ahead what to ask–but don’t hesitate to ask any new questions you think of while you’re there.
  3. Write down your questions in advance, to make sure you remember to ask them all.
  4. Write down the answers, so that you can review them whenever you want.
  5. Consider bringing a tape recorder to make a taped record of what’s said (even if you write down answers).

 

Ten Things to Know About Cancer Treatment Trials

  1. Clinical trials are research studies that involve people.  Each study tries to answer scientific questions and to find better ways to prevent, diagnose or treat cancer.
  2. In cancer research a clinical trial is designed to show how a particular anticancer strategy — for instance, a promising drug, a gene therapy treatment, a new diagnostic test, or a possible way to prevent cancer — affects the people who receive it.
  3. A clinical trial is one of the stages of a long and careful cancer research process.  Getting promising results from testing a new drug on mice, for example, is a preliminary step to human research studies. Treatments that work well in mice do not always work well in people.
  4. People can benefit from clinical trials. In treatment trials, for example, participants receive high-quality cancer care — and will be among the first to benefit if a new approach is proven to work.
  5. Who’s eligible to participate in a clinical trial?  Each study has its own guidelines for who can participate.  Generally, participants are alike in key ways – such as the type and stage of cancer, age, gender, and other factors.
  6. Are there drawbacks? New treatments under study are not always better than, or even as good as, standard care.  And they may have unexpected side effects.  Through a process called informed consent you will learn about a study’s treatments and tests, and their possible benefits and risks, before deciding whether or not to participate.
  7. Do some people receive a placebo in clinical trials?  In treatment trials, involving people who have cancer, placebos are very rarely used.
  8. 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.
  9. Where do clinical trials take place? They are underway all over the country – in cancer centers, other major medical centers, community hospitals and clinics, physicians’ offices and veterans’ and military hospitals in numerous cities and towns around the United States.
  10. Who pays for the patient care costs on clinical trials?  Health plans and managed care providers do not always cover all patient care costs in a study.  What they cover varies by plan and by study.  Ask a doctor, nurse or social worker from the study to help you determine in advance what costs are covered.  The research costs, such as data management, are covered by the study sponsor.