Cancer Clinical Trials:
The Basics
What Are Cancer Clinical Trials?
· Research studies
involving people
· Try to answer
scientific questions and
find better ways to
prevent, diagnose, or
treat cancer
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Why Are Cancer Clinical Trials
Important?
· Cancer affects all of us
· Each year in the U.S.A:
­ More than half a million
people are expected to die of
cancer -- more than 1,500
people a day
­ 1 of 4 deaths is from cancer
­ More than 1 million new
cancer cases are expected to
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be diagnosed
Why Are Cancer Clinical Trials
Important?
· Clinical trials translate
results of basic scientific
research into better ways to
prevent, diagnose, or treat
cancer
· The more people that take part, the faster we can:
­ Answer critical research questions
­ Find better treatments and ways to prevent cancer 4
Do Many People Participate in
Cancer Clinical Trials?
· Only 3 percent of U.S.
adults with cancer
participate in clinical
trials
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Types of Cancer Clinical Trials
· Treatment trials
· Prevention trials
· Early-detection trials/screening trials
· Diagnostic trials
· Quality-of-life studies/supportive
care studies
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Clinical Trial Phases
Phase 1 trials
· How does the agent affect the human body?
· What dosage is safe?
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Clinical Trial Phases
Phase 2 trials
· Does the agent or intervention have an effect
on the cancer?
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Clinical Trial Phases
Phase 3 trials
· Is the new agent or intervention (or new use of
a treatment) better than the standard?
· Participants have an equal chance to be
assigned to one of two or more groups
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Randomized Trials
Participants have an equal chance to be assigned
to one of two or more groups:
· One gets the most widely accepted treatment
(standard treatment)
· The other gets the new treatment being tested,
which researchers hope and have reason to
believe will be better than standard treatment
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Randomization
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Why Is Randomization
Important?
· So all groups are as alike as possible
· Provides the best way to prove the
effectiveness of a new agent or intervention
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Cancer Treatment Trials
· What new treatments
can help people who
have cancer?
· What is the most
effective treatment for
people who have
cancer?
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Cancer Treatment Trials
Placebos are almost never used:
· Placebos are used only when no standard
treatment exists
· Patients are told of this possibility before
deciding to take part
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Cancer Prevention Trials
· Evaluate the
effectiveness of ways
to reduce the risk of
cancer
· Enroll healthy people
at high risk for
developing cancer
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Cancer Prevention Trials
· Action studies
("doing something")
· Agent studies
("taking something")--
also called
"chemoprevention
studies"
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Chemoprevention Trials
· Phase 3 chemoprevention trials compare a
promising new agent with either a:
­ Standard agent
­ Placebo
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Clinical Trial Protocol
· A recipe or blueprint
· Strict scientific guidelines:
­ Purpose of study
­ How many people will participate
­ Who is eligible to participate
­ How the study will be carried out
­ What information will be gathered about participants
­ Endpoints
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Benefits of Participation
Possible benefits:
· Patients will receive, at a minimum, the best
standard treatment
· If the new treatment or intervention is
proven to work, patients may be among the
first to benefit
· Patients have a chance to help others and
improve cancer care
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Risks of Participation
Possible risks:
· New treatments or interventions under study
are not always better than, or even as good
as, standard care
· Even if a new treatment has benefits, it may
not work for every patient
· Health insurance and managed care
providers do not always cover clinical trials
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Patient Protection
· There have, unfortunately,
been past abuses in patient
protection
· Federal regulations ensure
that people are told about
the benefits, risks, and
purpose of research before
they agree to participate
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How Are Patients' Rights
Protected?
· Informed consent
· Scientific review
· Institutional review boards (IRBs)
· Data safety and monitoring boards
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How Are Patients' Rights
Protected?
Informed consent:
· Purpose
· Procedures
· Risks and potential
benefits
· Individual rights
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How Are Patients' Rights
Protected?
· Scientific review
· Institutional review boards (IRBs) are required
by Federal law for trials that are:
­ Federally funded
­ Subject to FDA regulation
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How Are Patients' Rights
Protected?
Data and safety monitoring boards:
· Ensure that risks are minimized
· Ensure data integrity
· Stop a trial if safety concerns arise or
objectives have been met
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Why Do So Few Cancer Patients
Participate in Clinical Trials?
Sometimes patients:
· Don't know about clinical trials
· Don't have access to trials
· May be afraid or suspicious of research
· Can't afford to participate
· May not want to go against physician's wishes
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Why Do So Few Cancer Patients
Participate in Clinical Trials?
Doctors might:
· Lack awareness of appropriate clinical trials
· Be unwilling to "lose control" of a person's
care
· Believe that standard therapy is best
· Be concerned that clinical trials add
administrative burdens
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NCI Information Resources
· NCI Web site
www.cancer.gov
· Cancer Information Service
­ 1-800-4-CANCER
­ TTY- 1-800-332-8615
­ www.cancer.gov/cis
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