Applied Clinical Trials eBook - June 2014 - (Page 16)
ONCOLOGY
Patient-First Approach to
Improve Oncology Trials
Linda Strause
Ethical issues pertaining to subjects facing lifethreatening disease-a personal account.
L
ife can change in an instant, but there is one
thing that always abides: hope. Understanding
the reality that comes when one is faced with
a life-threatening disease and understanding
how hope, the unfailing feeling and expectation
that tomorrow will be better, challenges autonomous
decision-making and explains why, only 3% to 5% of
cancer patients participate in clinical trials. Although
oncology projects account for almost 31% of global
projects,1 they remain the most difficult therapeutic
area in which to conduct clinical trials. As an industry we must learn to put the patient at the center
of the clinical trial enterprise and see clinical trials
through their eyes.
Click to listen to two podcasts with Linda Strause: Oncology Clinical Trials: Patients on the Edge of Hope, and Science
and Getting to the Heart of Poor Oncology Enrollment.
My personal story
The definition of hope, a feeling of expectation
and desire for a certain thing to happen, seems
simple but managing that hope isn't. Managing
hope became a reality as I began my journey that
day in April when I heard the neurosurgeon say:
"Your husband has glioblastoma multiforme (GBM),
an extremely aggressive, highly vascularized, and
incurable brain cancer." Through this journey I
learned, from both a personal and professional
perspective, that although hope remains a constant, hope changes form. When our neurosurgeon
said, "someone is on the right side of the curve,"
it made perfect sense to me as a clinical research
professional. In the beginning we hoped for a cure.
With time and disease progression hope changed.
16
APPLIED CLINICAL TRIALS
A balance must be found between the hope that
standard of care will work, the hope that the investigational agent in a randomized clinical trial
will work, and the hope that there will be dignity in
death. Hope changes and how it changes is based
on actual alternatives available to the patient at any
given time. Plans for a dinner party hit a snag when
58-year-old Randy, my husband of 35 years, with noticeable concern in his voice, remarked that he just
"didn't seem right." I called the doctor, who advised
a trip to the emergency room. "Everything seemed
so normal until I took him into the emergency department. All of a sudden someone was asking my
husband to count backwards by 10 and he couldn't
do it."2 Rather than enjoying a pleasant dinner with
friends, we embarked on our new reality.
A glioblastoma tumor is like an octopus. It's difficult to surgically remove all the tendrils without
jeopardizing the brain. Consequently, even when the
primary tumor is removed, microscopic ones remain.
Doctors recommended a three-phase treatment plan.
A balloon implanted during surgery would be injected
with radioactive iodine and removed after six days.
Randy would later receive local radiation five days a
week as well as low-dose chemotherapy daily for five
weeks. In mid-summer he would receive high-dose
chemotherapy five times over the course of a month.
Even with a plan in place, I began exploring options. It's hard to imagine anyone better suited to
navigating the clinical trial process than I was. I have
a doctorate in neurophysiology and was at the time
the executive director and head of clinical operations
at a biotech, managing a Phase III melanoma trial.. I
suddenly found myself completely responsible for
appliedclinicaltrialsonline.com
June 2014
http://bcove.me/jemdam74
http://bcove.me/jemdam74
http://bcove.me/fiohpiw6
http://bcove.me/fiohpiw6
http://www.appliedclinicaltrialsonline.com
Table of Contents for the Digital Edition of Applied Clinical Trials eBook - June 2014
Applied Clinical Trials eBook - June 2014
Contents
Analyzing 2013 Oncology Trends to Predict 2014 Directions
New Road of Cardio-Oncology in Clinical Development
Partnering Early for Successful Oncology Drug Development
Translational Medicine and Biomarkers
Immunotherapy Clinical Trials in Melanoma
Patient-First Approach to Improve Oncology Clinical Trials
Applied Clinical Trials eBook - June 2014
https://www.nxtbook.com/nxtbooks/actebooks/act_201506
https://www.nxtbook.com/nxtbooks/actebooks/act_201505
https://www.nxtbook.com/nxtbooks/actebooks/act_201503
https://www.nxtbook.com/nxtbooks/actebooks/act_201412
https://www.nxtbookmedia.com