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What is the purpose of clinical
trials?
To ask specific scientific questions to find
better ways to prevent, detect, or treat
diseases or to improve care for people with
diseases
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What is the number one reason cancer
patients participate in clinical trials?
a. The doctor recommended it
b. They saw an ad in the newspaper
c. They did research on their own/found it
on the internet
a. The doctor recommended it
RL Comis, D. Colaizzi and J. D. Miller Cancer clinical trials (CCT) awareness and attitudes in cancer of
Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Vol 24, No 18S (June 20 Supplement), 2006: 6061
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True or False?
Cancer clinical trials are only for
people who have no other
options left.
FALSE
There are trials for all kinds of
cancers, from the most advanced to
the ones found very early.
Fact
Clinical trials are not only for those patients
with the most advanced disease; many patients
get first line treatment through a clinical trial.
At first treatment, in the
adjuvant setting, at
recurrence…
How can we ensure that
every patient feels confident
to ask, “is there a trial for
me?”
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True or False?
New approaches being tested in
clinical trials are probably more
effective than the current or standard
treatment.
FALSE
New methods may or may not be better than
current treatment.
A Phase 3 study goal is to determine whether
there is a difference.
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True or False?
The reason clinical trials are done is that
no one yet knows if a new treatment…
1. Is safe
2. Is effective
3. Will turn out to be better than the
approaches currently being used
TRUE
These are also the three phases of clinical
trials.
There Are 3 Phases of Clinical Trials
Phase 1 trials
• Is it SAFE?
Phase 2 trials
• Does it WORK?
Phase 3 trials
• Is it BETTER than what is used now to treat this
cancer?
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True or False?
Cancer clinical trials seek to find
better types of cancer treatments
FALSE
There are many types of cancer clinical
trials.
Fact: There are Many Types of
Clinical Trials
• Treatment
– Even as 1st line
• Prevention/
chemoprevention
– For primary or
secondary cancer
• Diagnostic
• Genetics
• Quality-of-life/
supportive care
• Screening and early
detection
There are different types of cancer clinical
Another way to look at it…
trials
• For people who have cancer
– Treatment
– Genetics
– Quality-of-life/supportive care
• For people at high risk for getting cancer
– Prevention
– Genetics
• For people being screened for cancer
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3 percent vs. 70 percent
What is the percentage of adult cancer
patients participating in cancer clinical trials
vs. pediatric cancer patients?
More children 0-14 surviving
cancer due to CCTs
Very Few People Participate
• Less than 3% of all cancer patients receive
treatment through a clinical trial (20%
eligible)
– Participation rate is even lower among people
of color, older people, and the medically
underserved
• who tend to have higher cancer mortality rates
than the population as a whole.
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True or False?
In randomized clinical trials, patients
are assigned to different groups by
an objective group of scientists and
physicians.
FALSE
Patients are usually assigned through a
computer. Neither the patients nor the doctors
can choose the group they want.
In Many Clinical Trials, Participants
Are Placed into Different Groups
All have an equal chance to be assigned to
one of two (or more) groups:
• One gets the most widely accepted
treatment
• The other(s) gets the new treatment being
tested, which doctors hope will be better
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True or False?
In cancer treatment trials, patients may be
given a placebo instead of being
appropriately treated for their cancer.
FALSE
Placebos are never used to substitute for
appropriate medical care.
Patients Are Always Treated for
Their Cancer
• In cancer treatment trials, everyone
gets treated
– Placebos or “sugar pills” are almost
never used instead of appropriate
treatment
Trial 123
Standard
Treatment being
studied
Trial 456
Standard & Placebo
Standard & “Zing,” a
treatment being
studied
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True or False?
Patients who join clinical trials today
aren’t going to benefit from taking part
FALSE
While it’s not yet known if the new treatment is
going to work better than what is currently used,
patients can and do benefit from participating.
Helping Individual Patients Today:
A High Quality Treatment Option
Open to many patients, even for first treatment
– “The best management for any patient with cancer
is in a clinical trial.” (NCCN, 2008)
– “Therapies offered through CCTs should ideally be
considered the preferred treatment choice for
physicians and patients, if they are available”
(Institute of Medicine, 2010)
Placebos never used instead of appropriate medical
treatment
Also important for future patients
The only way we will find better ways to treat
cancer is through clinical trials…
Chance for
survival,
1975-1977, all
cancers:
Chance for
survival, 19992005, all
cancers
50%
68%
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True or False?
In general, doctors will always suggest
cancer trials as a treatment option
for a patient who is eligible.
FALSE
Both health care providers and patients lack
knowledge about clinical trials.
Cancer Clinical Trials
 Researchers “have difficulty” in recruitment and
retention, especially among minority groups
 Up to 30% of phase III trials close early
 Referrals (or encouragement) from PCPs,
surgeons and non-participating oncologists needs
to be better
 Poor understanding among patients and members
of the public
 Distrust, fear and suspicion
Who is Offered the Opportunity
to Participate?
• Most cancer patients are unaware that
clinical trials were a treatment option
• Minorities may be as willing to participate
in research but are less likely to be asked
• Consider the “narrow window” of
opportunity
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What is the main purpose of a clinical trial
protocol?
a. To allow physicians to individualize each
patient’s case
b. To ensure high-quality patient care
c. To describe how the study will be carried
out
d. None of the above
c. To describe how the study will be carried out
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This is something that ACA
mandates…
along with 36 states
What is insurance coverage for patient costs
in cancer clinical trials
Fact
• Health insurance and managed care providers
often do not cover the patient care costs
associated with a cancer clinical trial.
– What they cover varies by health plan and by
study.
• 36 states currently mandate insurance
coverage for these trials.
• Medicare covers many patient care costs in
cancer clinical trials.
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The tragedy of the Tuskegee Study brought this
right to all persons participating in any
clinical trial.
a.
b.
c.
d.
Randomized study design
To be informed about risks
Informed consent form
Informed consent process
d. Informed consent process
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Why don’t more patients participate
in clinical trials?
a. Fear
b. Don’t know about them
c. Fear that it won’t be paid for by insurance
d. Mistrust
e. All of the above
e. All of the above
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Why are there restrictions as to who can
participate on clinical trials?
a. To protect patients safety
b. To ensure study results are accurate and
meaningful
c. To limit trials to a certain number of
participants
d. Both a and b
d. To protect patients’ safety and to ensure study
results are accurate and meaningful
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In the only study of 6000 cancer patients,
this is the percentage that were
actually informed about the possibility
of receiving treatment through a
clinical trial.
What is 15%
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20% of all cancer patients;
3% of all cancer patients;
Who is eligible for CCT participation
vs. who participates in CCTs?
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The process of providing all relevant
information about the trial's purpose,
risks, benefits, alternatives, and
procedures to a potential participant.
What is the Informed Consent Process
Informed Consent
They must be told about…
• The purpose
• The procedures
• The risks and potential
benefits
• Their individual rights
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True or False?
In a national study of 6000 cancer patients,
85% were informed that clinical trials were a
treatment option, but declined to participate.
FALSE
85% of cancer patients surveyed
were uninformed that clinical trials
were a treatment option; 75% of
them would have been willing to
participate
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True or False?
Most patients are uninterested
in participating in research
FALSE
Almost Final
Jeopardy
Make Your Wager
Now…
Name a barrier for clinical
trials from the perspective of
a) participating oncologist b)
cancer patient c) primary
care provider; d) non
participating oncologist
Patient and Physician Barriers to Clinical Trial Access
(Source: Cancer Clinical Trials: A Guide for Outreach and Advocacy (NCI) (Unless Otherwise Noted)
Physician Barriers
Patient and Environmental Barriers
A physician’s recommendation is often the primary factor influencing patients’ decisions to enroll
in a trial.1 Yet, each group of providers involved in patients’ diagnosis and treatment face unique
For all Patients
barriers to facilitating patient access to clinical trials.
Participating Oncologists
Non participating
Oncologists/ Surgical
Oncologists
For Medically Underserved
Groups in particular *
Primary Care Providers
doing diagnostic
workup, prior to referral
2
May not offer treatment through a clinical
trial to all that would otherwise qualify by:
 assuming disinterest on the part of
their patients
 inadvertently discriminating against
older people or the medically
underserved3, 4,5
 avoiding the subject out of concern
they would be seem as insensitive.
May not have the skills, ability or
resources to conduct appropriate
recruitment within the community6.7
May feel the extra effort required to
consent minority patients or the medically
underserved is not important for their
research.8




May lack awareness of
appropriate local clinical
trials
May be unwilling to “lose
control” of a person’s care
May believe that standard
therapy is best, or
May feel that referring to or
participating in a clinical
trial adds an excessive
administrative or cost
burden to the practice.
May not feel suited to
discuss the topic with
patients.9
May lack awareness of
appropriate local clinical
trials10






May lack awareness11 
May lack access
May face payment12 or
other logistical barriers
May not meet eligibility 
criteria
May be fearful,

distrusting, or
suspicious of research
May believe common
myths 13

may have long-standing fear,
apprehension, and skepticism
about medical research
because of past abuses
may hold values and beliefs
different from those of Western
medicine.
may face language and literacy
differences can create
additional barriers to effective
communication
may have co-morbidities,
which disproportionately
impact their eligibility 14
*These groups comprise government-designated ethnic and racial groups, including American Indian/Alaska Natives; Asians; African-Americans; Hispanic/Latinos; and Native Hawaiian and other Pacific Islanders. They also
include rural residents and people of low income and low literacy.
1
Kinney, A. Y., Richards, C., Vernon, S. W., & Vogel, V. G. (1998). The effect of physician recommendation on enrollment in the Breast Cancer Chemoprevention Trial. Prev Med, 27(5 Pt 1),713-719.
Awareness Barriers/
Promoters
Opportunity
Barriers/Promoters
Barriers/Promoters
Knowledge
Provider Knowledge
Perceived Harms/Benefits
Attitudes/Beliefs
Provider
Attitudes/Beliefs
Trust in Sponsor/Investigator
Self-Efficacy
Organizational
Environment
Health Literacy
Eligibility/Exclusions by
Design Access
Medical Insurance
Advanced Disease
Co-morbidity
Organizational
Environment
Acceptance/Refusal
Self-efficacy
Altruism
Religious Beliefs
Personal Experience
No Cost Treatment
Financial Incentives
Timing
Opportunity
Awareness
Acceptance/
Refusal
Final Jeopardy
Make Your Wager
Now…
Name 3 risks and 3 benefits
for patients who choose to
take part in clinical trials
Final Jeopardy Possible Answers…
BENEFITS
• 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
• If the approach being studied is found to be helpful,
patient may be among the first to benefit
• An opportunity to make a valuable contribution to
cancer research
Final Jeopardy Possible Answers…
RISKS
• New drugs and procedures may have
unknown side effects or risks
• 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 all