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Deciding Whether to Take Part in a Clinical Trial
Should I Take Part in a Clinical Trial?
Only you can make the decision about whether or not to participate in a clinical trial.
Before you make your decision, there are a number of things you should consider:
1. Learn about your specific disease.
2. Understand what a clinical trial is.
3. Find out about the clinical trials that might be appropriate for you.
4. Get answers to all of your questions.
5. Determine the potential risks and benefits of your participating in a clinical trial.
6. Talk about this information and how you feel about it with your own doctor and/or
nurse, family members and friends to help you determine what is right for you.
Risks and Benefits of Participating in Clinical Trials
As you weigh the risks and benefits of clinical trial participation, you may want to
consider the following:
The 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
If the approach being studies is found to be helpful, you may be among the first to
benefit
An opportunity to make a valuable contribution to cancer research
The potential risks include:
New drugs and procedures may have side effects or risks unknown to the doctors
Side effects and results may be worse than from interventions that are currently standard
Even if a new approach has benefits, it may not work for you
Health insurers and managed care providers do not always cover all the care costs in a
clinical trial
Discussions with your doctor, nurse, family and friends combined with knowledge from
cancer information sources like this site, will help you make better decisions about your
healthcare options including clinical trials.
What Happens in a Clinical Trial?
If you decide to join a clinical trial, you will work with a research team. Team members
may include doctors, nurses, social workers, dietitians, and other health care providers.
They will provide your care, monitor your health carefully and give you specific
instructions about the study. This 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, it's important for participants to follow the research team's instructions. That
means having all doctor visits and tests, taking medicines on time, and completing logs or
answering questionnaires.
What is 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. These facts include details about the
study approach, the intervention actually given in the trial, the possible risks and
benefits, and the tests you may have. The research doctor or nurse will give you written
information called a consent form that goes over key facts. If you agree to take part in
the study, you will be asked to sign this form. You are encouraged to take the form home
and discuss it with your family, friends, or others before you make your decision. If you
do decide to join the clinical trial, be sure to ask for a copy of the consent form, so
you can look it over at any time.
Don't hesitate to ask questions until you have all the information you need. This is an
important decision, and you should be comfortable with whatever choice you make. In fact,
you should feel free to ask the research team questions at any time.
Informed consent is more than a form; it's a process that continues throughout the study.
For example, you may continue to have questions throughout the study, and your discussions
about these questions with the health-care team are all part of the informed consent
process.
You can leave the study at any time. Informed consent continues as long as you're 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.
Questions to Ask When Considering a Clinical Trial
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 some you 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, 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 the 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 many travel or child care costs that I need to consider while I am in the
trial?
Tips for Asking your Doctor about Trials
When you talk with your doctor or members of the research team:
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).
Source: National Cancer Institute
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