Transcript Clinical Trials Bridging the Gap

Cancer Clinical Research
Options for Cancer Survivors
Jeannette Mendez, BA, CCRP
Cancer Disparities Research Coordinator
Mayo Clinic Arizona
What is cancer Clinical Research?
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Cancer clinical studies are conducted by
medical scientists to improve the care and
treatment of cancer patients
Cancer clinical studies test new ways to:
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Diagnose and treat cancer in people
Prevent or reduce disease or treatment side
effects
Prevent or treat a recurrence of cancer
Improve the comfort and quality
of life of people with cancer
Background
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ACS estimated about 30,000 individuals in
Arizona received a cancer diagnosis in 2010
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An estimated 20% of all adult cancer patients are
medically eligible for a cancer clinical trial
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Trial participation in the US remains between 35% in the general population and 1% in minority
groups.
Types of Studies
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Screening
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Prevention
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Treatment
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Quality of Life
Screening
•Test the best way to find cancer, especially in its early stages
Genetics
Laboratory
Imaging
Prevention
Test new methods, like medicines, vitamins, minerals, or other
supplements that doctors think may lower the risk of a certain type of
cancer
Two kinds of prevention clinical studies
Action studies (doing something)
Find out whether actions people take, such as exercising
more or quitting smoking, can prevent cancer.
Agent studies (taking something)
Find out whether taking certain medicines, vitamins,
minerals or food supplements (or a combination of them)
can prevent cancer.
Treatment Studies
Test new treatments
new cancer drugs
new ways of doing surgery or radiation therapy
new combinations of treatments
new methods such as gene therapy
Are placebos used in cancer
treatment clinical trials?
Placebos also known as “sugar pills” are rarely
used in treatment trials! In fact, it is unethical to
not treat a patient during their cancer journey!
Patients must minimally receive standard care.
Quality of Life
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Look at ways to improve comfort and quality
of life for cancer patients
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Cancer control
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Symptom management
Phases of a Study
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Objective: To establish a drug’s pharmacokinetic profile and
safety profile
Protocol is less detailed to allow more design flexibility
Phase I answers:
 What is the correct dose?
 What are the side effects?
 How is the drug metabolized?
 Safety/tolerability?
First time in human subjects
Pharmacokinetics / pharmacodynamics
Open label, often single center
Not always performed in the U.S.
Case Example #1
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Native American, Female, metastatic breast
cancer, Triple Negative, 3 prior chemo
regimens, exhausted options at home
institution
Would be eligible for studies that allow her
indication and can range from phase 1 to 4.
Mayo had 5 options for her at one point
excluding phase 1!
Case Example #2
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Hispanic, Female, newly diagnosed breast
cancer, indicated for masectomy with a mass
larger than 2cm. Patient wants other options.
Patient eligible for neo-adjuvant study where
she received chemo before surgery, and her
tumor shrunk enough for her to have breast
conservation surgery saving her from
completely removing her breast.
Learning about clinical trials
 Study
Design
 Eligibility
 Safety
 Costs
Study Design
Each cancer clinical study has a written detailed
design, called the protocol, that includes:
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background of why the clinical study is needed
the purpose of the study
what drug or drugs are being tested, along with a
treatment and follow-up schedule
safety measures to be followed throughout the
clinical study program
Eligibility
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Clinical studies…
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are not only for people with the most advanced
disease
can also be for people with newly diagnosed or very
limited disease
are appropriate for different types of people,
depending on the purpose and phase of the study
take into account age, gender, race, stage of disease,
other treatments used, and presence of any other
illness
Safety
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Each study is managed according to a strict set of
rules intended to protect patients
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quality of care
safety of participants
Researchers must explain the purpose, benefits, and
risks of a clinical study before a patient gives consent
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must be in a language they understand
they can ask questions if anything is unclear
they can have a language interpreter if needed
they may bring an advocate
Costs
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Costs that are usually covered by the sponsor at no cost to
the patient:
• research physician and nurse time
• cost of the drug being studied
Costs that may not be covered by private or public health
insurance are those that a patient would have whether or
not he / she was in a clinical trial:
• hospitalizations
• doctor visits
• laboratory tests
• drugs that are not part of the study design
If trials are successful, What gets in
the way?
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Cancer patients may not have access to clinical studies
e.g., under-insured or have no insurance, worry about cost
Mayo Clinic ADVOCATES-Economic hardship and Pharmacy
Assistance Programs
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may fear or distrust medical research
I don’t want to be a “guinea pig”
Mayo Clinic EDUCATES-The Clinical Trial Process
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may face practical obstacles:
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Transportation, meals, housing
Mayo Clinic provides SUPPORT through an ACS patient
navigator.
If trials are successful, what gets in the
way?
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Cancer Patients …
 may lack health literacy
 may not want to ask their current doctor about
studies, or do not want to go against their doctor’s
wishes
Mayo Clinic provides TRANSLATORS.
 may be less likely to participate in clinical studies if
 they belong to an ethnic minority, or
 they are older / aged
Mayo Clinic employs CULTURALLY COMPETENT
staff.
Critical Barrier in Cancer
Clinical Trials
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Unaware of the option of participating in
clinical trials. Research has consistently
shown that most people are not aware that
clinical trials could be an option for cancer
treatment or prevention.
To achieve a balance in health literacy, clinical
trial Awareness is vital.
A promise for the future
If we, as a population
understand cancer
research trials as a
therapy option, then
we may extend the
life of those we love.
Participation in clinical trials:
What gets in the way?
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Doctors might…
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be unaware of available clinical studies
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believe that standard therapy is best
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be concerned about administrative burdens
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be unwilling to “lose control” of a patient’s care
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be concerned about how a patient will react to
the suggestion of a clinical study
Mayo Clinic educates members of the
community on the need for minorities in
cancer clinical trials.
A Mayo Research Experience
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Diagnosis- Patient informed of treatment
options. Research always included.
Consent-Patient is informed of study and
asked if interested.
Screening- Staff makes sure patient is
eligible. This is a safeguard.
Enrollment- Eligible patients enrolled.
A Mayo Research Experience
Active Treatment- Patient closely
monitored by physician and research
staff.
Completion- Patient completes research
therapy
Follow Up- Patient is followed through
study regulations.
#1 priority is the patient’s safety and well
being!
Research Collaborations
Targeting increased minority enrollment in
cancer trials, Mayo Clinic currently engages
in research with:
-Maricopa Integrated Health Systems
-Mountain Park Health Center
-Phoenix Indian Medical Center
-Arizona State University.
Minorities in Research
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Evidence of genetic variance in responses to
cancer drugs!
Lack of minority representation in cancer
research causes lack of true efficacy.
The solution to end disparity in medicine is to work
together. Like the pieces of a jigsaw puzzle,
each race’s genetic make-up is unique.
Advocating Cancer Trials
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Participation in cancer research is key.
Clinical Trial Education necessary for this to
be achieved. Medicine is the glue that keeps
us together and working towards a main goal.
By full participation of all, we interlock these
jigsaw puzzles and work to advance medicine
as a team.
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Research at your institution…
Risk
Solutions
1.Communication barriers wit participants.
2.Barriers to acceptance within community
health centers and physicians
3. Lack of patient participation
4. Lack of space availability to conduct
studies.
5. Lack of sufficient finances for legal, IRB,
or web maintenance services.
6. Lack of resources to complete projects
within designated time frames.
1.Culturally competent and trained
research teams
2.Guidance from Mayo Clinic resources to
assist in promoting ideas.
3. Create events to foster trust.
4. Advocacy to further institutions such as
schools and churches.
5. Seek economic hardship support from
pharmacy assistance programs
6. Collaborate with current leading
academic institutions for personnel
support.
What can we do?
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Know your community and it’s resources
Create partnerships and establish relationships
Provide education to the community, its leaders
and key stakeholders
Listen to the needs of the community
Be sensitive to the words you use to describe the
clinical trials process
“The needs of the patient
come first”-Mayo Clinic
“One must not forget that recovery is
brought about not by the physician, but by
the sick man himself. He heals himself, by
his own power, exactly as he walks by
means of his own power, or eats, or thinks,
breathes or sleeps”
~Georg Groddeck
Contact Info
Jeannette Mendez
Cancer Disparities Research Coordinator
(480)301-6478
[email protected]