Finding Your Passion for Research
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Transcript Finding Your Passion for Research
Clinical Trials: Finding Your
Passion for Research
Shannon Benson, RN, MSN
Administrator
Iowa-Wide Oncology Research Coalition
Who is I-WORC?
Iowa Oncology Research Association
Funded by the National Cancer Institute
Established in 1978
8 Sites: Des Moines, Blank, Mason City,
Ames, Cedar Rapids x 2, Ottumwa,
Moline
Organizational Chart
NCI
Research
Bases
Community
Sites
I-WORC
Goal for my 45 Minutes with You
My personal excitement for research
“The work that we do is important for a
number of reasons and therefore, it is
important to do good work.”
My Goal/Purpose for this talk
“In our field, we have a chance to be part of
something big.”
Dr. John A. Clements, M.D.
Recipient of the 2008 Pollin
Prize
In 1953, Dr. John Clements
made a discovery about how
the lungs work production
of synthetic surfactant
lowered the mortality rate of
RDS in premature babies
from over 90% to under 5%
At the age of 92, Dr.
Clements still comes to work
every day. When asked why,
he says there's always the
chance that a new day will
bring a new scientific insight
Research Basics
Clinical trials are a critical part of the research
process
◦ Today’s most effective treatments are based on
previous study results
The more people who participate, the faster
critical research questions can be answered
This will lead to better treatment and prevention
options for all cancers
In the past, clinical trials were seen as the last
resort for patients with no other treatment
options
Studies we Offer
Phase 2: How well the treatment works
◦ Less than 100 people
◦ Determining if the agent has an effect on a
particular cancer
◦ How the agent affects the human body
◦ In general, phase 2 participants have been
treated previously, but the treatment wasn’t
effective
Phases Continued
Phase 3: Comparing a new treatment to the
standard treatment
◦ Anywhere from 100 to 1000’s of people
◦ Purpose: to compare a new agent to the standard
◦ Control group vs. investigational group
◦ Majority of studies at IORA
◦ Ex: Ph III Trial of CHOP versus R-CHOP
Why research takes extra work?
Physicians
◦ Have to follow a protocol
Eligibility criteria, how to treat, dose mods, how
often to be seen, tests to order
◦ Loss of control
◦ Scrutiny of audits
Nurses
◦ Constant communication with research staff
Schedulers
How I Encourage Our Staff
It’s not enough to just be
◦ Smart
◦ Great at Your job (audits ensure this)
They also have to be enthusiastic
◦ Portray/model enthusiasm and hope that it is
infectious
When they feel like it’s just too much, I
remind them of why we do what we do
A Couple Exciting Studies
MATCH
COMET
S0820/PACES
A011401
MATCH Trial
National cutting edge Precision Medicine Trial
Explores treating patients based on the molecular
profiles of their tumors
For adults with solid tumor and lymphomas that
no longer respond to standard treatment
Biopsied tumor tissue will undergo gene
sequencing. Gene sequencing will look for
changes in 143 genes. If a patients tumor has a
genetic abnormality that matches one targeted by
a drug used in the trial, the patient will be eligible
to join the treatment portion of the MATCH trial
COMET
COMET: COMmunication and Education
in Tumor Profiling
an ancillary study to MATCH
Can web-based genetic education address
gaps in the delivery of precision medicine?
COMET cont.
Patients report benefits of tumor profiling, but 71%
report potential disadvantages (loss of hope,
disappointment, unwanted information)
Oncologists report less confidence providing
psychosocial support and psychosocial counseling about
secondary germline testing for potential inherited
incidental findings
Patients are randomized to usual care alone or usual
Care + Self-Guided Online Genetic Education
S0820/PACES
A Double Blind Placebo-Controlled Trial
of Eflornithine and Sulindac to Prevent
Recurrence of High Risk Adenomas and
Second Primary Colorectal Cancers in
Patients with Stage 0-III Colon or Rectal
Cancer
Primary Objective: to assess whether eflornithine
500 mg or sulindac 150 mg are effective in reducing
the 3-year rate of high risk adenomas or second
primary colorectal cancers in stage 0, I, II, and III
colon or rectal cancer patients
Background
Among colorectal adenoma patients
treated for 3 years with either
placebo/placebo or eflornithine/sulindac,
a 70% reduction in total adenomas was
observed for the intervention group
More importantly for the field of cancer
prevention was the effect of
eflornithine/sulindac on advanced
adenomas and multiple adenomas:
where >90% reductions were observed
(ie, these are the types of adenomas that
are more likely to progress to CRC)
A011401
Randomized Phase III Trial
Evaluating the Role of Weight Loss
In Adjuvant Treatment of
Overweight and Obese Women with
Early Breast Cancer
Indirect evidence that purposeful
weight loss could lower risk of
recurrence
Schema
3136 participants
Key Eligibility:
•Stage II-III breast
cancer
•HER-2 •BMI ≥ 27 kg/m2
R
A
N
D
O
M
I
Z
E
2-year telephone-based
weight loss intervention +
Health education
Health Education
Alone
Research Matters
We KNOW it’s extra
work
Support the research
staff
Clinical Trial Resources
NCI resources
◦ 1-800-4-CANCER
◦ www.cancer.gov/clinicaltrials
NIH
◦ www.clinicaltrials.gov
Iowa Oncology Research Association
◦ www.iora.org
◦ 515-241-3305
Perspective
Our Team
Shannon Benson,
RN, MSN
Administrator
IORA, I-WORC
1221 Pleasant St.
Suite 450
Des Moines, IA
50309
[email protected]
515-241-3305
Thank you!
For your time and
attention
Any questions