Some Questions
To Ask Before Entering a Clinical Trial
The Study
- What is the
purpose of the study?
- Why do researchers
think the approach may be effective?
- Who will sponsor
the study?
- Who has reviewed
and approved the study?
- How are study
results and safety of participants being checked?
- How long will
the study last?
- What will my
responsibilities be if I participate?
- What is the
protocol if I’m part of the control group instead of the clinical
trial?
Possible Risks
and Benefits
- What are my
possible short-term benefits?
- What are my
possible long-term benefits?
- What are my
short-term risks, such as side effects?
- What are my
possible long-term risks?
- What other
(treatment) options do people with my risk level or type of cancer
have?
- How do the
possible risks and benefits of this trial compare with those options?
Participation
and Care
- What kinds
of therapies, procedures and/or tests will I have during the trial?
- Will they
hurt, and if so, for how long?
- How do the
tests in the study compare with those I would have outside of the
trial?
- Will I be able
to take my regular medications while in the clinical trial?
- Where will
I have my medical care?
- Who will be
in charge of my care?
Personal Issues
- How could
being in this study affect my daily life?
- Can I talk
to other people in the study?
Cost Issues
- Will I have
to pay for any part of the trial such as tests or the study drug?
- If so, what
will the charges likely be?
- What is my
health insurance likely to cover?
- Who can help
answer any questions from my insurance company or health plan?
- Will there
be any travel or child care costs that I need to consider while
I am in the trial?
Basic Definitions
- Clinical Trials:
research studies that test how well new medical approaches work
in peopleProtocol: describes what will be done, how it will be done
& why it is necessary
- Eligibility
criteria: guidelines for who can or cannot participate in the study
Informed consent: the process by which people learn the important
facts about a trial
- Phase I studies
evaluate what dose is safe, how it should be administered, &
how often
- Phase II trials
study the safety & effectiveness and evaluate how it affects
the human body
- Phase III trials
compare a new drug with the current standard therapy
- Phase IV studies
evaluate long-term safety & effectiveness (usually after FDA
approval)
Only about 5%
of cancer patients participate in clinical trials
Clinical trials
can be sponsored by National Cancer Institute, National Institutes
of Health, medical institutions, pharmaceutical companies, federal
agencies, private companies, and nonprofit organizations
Find
Clinical Trials
top of page
