Download Clinical Trials: 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
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Z
E
2-year telephone-based
weight loss intervention +
Health education
Health Education
Alone
Research Matters

We KNOW it’s extra
work
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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
