Helping patients to understand the science, and
scientists to better understand patients Ė
who are the primary stakeholders in clinical
Clinical Cancer Research |
Iím very excited to begin to report on
two recent experiences as a patient research advocate.
One purpose of providing this topic is to help future
research advocates to know what is expected in this type of
advocacy; another is to help the patient community to better
understand the purpose of clinical trials.
Research advocates - what do we do?
Liaisons between research and public communities
Identify study priorities of importance to patients
Participate in disease and modality committees in
cooperative group research
Develop advocate-researcher communication strategies
Participate as a voting member in concept review
Advocate for input on study designs at earliest stages
Help to meet challenges of study accrual
Provide mentoring and education to other advocates & the
The ASCO-AACR Methods in Clinical Cancer Research Workshop
In no other venue is the role of advocates
understood and embraced more fully. And no other event is as
challenging and gratifying to all who are involved ... this
being a unanimous opinion!
Young researches first submit their
concepts to a committee. The winning applicants are then invited
to participate in a six day workshop and assigned to
different protocol development groups. Our group had nine young research
fellows. Each group includes 4 faculty members.
I was honored to participate as a
patient advocate with a very talented group of young
investigators and an
amazing faculty team:
Dr. Jamie H. Von
Professor of Medicine, Northwestern Univ. School of Medicine
Dr. Alfred W.
Professor, Dept. of Preventive Medicine Northwestern Univ.
Dr. Sandra Horning,
Clinical researcher and clinician at Stanford University,
president of ASCO, now employed at Genentech.
What is the role of the patient
advocates at the workshop?
As Doctor Lee M. Ellis noted in his opening
address, the advocates are here to help the young investigators
in many aspects of the protocol and consent document ... such as to keep us grounded:
... Your study protocol is asking the patients to do
Is the study
question of interest to the patient community?
Is the protocol attractive
to patients as a treatment decision?
eligibility exclusions too restrictive?
Are the tests,
biopsies, and procedures too burdensome?
informed consent document clearly describe how the study
protocol compares to regular care?
informed consent document contain what is needed to
help the patient choose? Is the language too
technical? Will it be understood by grandma?
(This part was more challenging than any young investigator
I was invited to participate in the panel
discussion on Laboratory Correlates, On this I submitted the
following background material: Giving Blood and Tissue -
Patient Perspectives PDF
... This year I did not have many
opportunities to add to the discussion because of the nature of
the questions, but in my introduction I noted that many patients
understand the need for predictive biomarkers. What is
worse than getting no benefit ... only the toxicities, which can
narrow the range of available options?
... I also suggested that investigators
collaborate with other groups for use of the tissue, to increase
the chance that the contribution made by the patient might help
them clinically, such as to determine eligibility for a
different clinical trial. Doing this could "sweeten the
pot" in cases where asking the patient to contribute is
challenging, based on the burden of the procedure. During
office hours, two young researchers thought this suggestion
could be helpful.
At Vail, advocates are
also asked to lead the discussion in the Protocol Development Groups
on the day before the informed consent documents are due; to comment
on aspects of the study protocols, such as the exclusion and
inclusion criteria; to review and provide guidance on the informed
consent documents; attend all the great lectures, and to make
ourselves available to the students during office hours - but also
to dine with and have amazing conversations with the faculty and
young research fellows.
Karl Schwartz, Patient advocate
Comments or Questions?
Scientific Committee Participation
One key to participation
is to stick to our areas of expertise -- and to know what we
don't know - such as to avoid critiquing the basic science
beyond reminding that clinical evidence trumps theories
About my experience on committee I can only discuss
it in general
terms Ö until next month when the final decision will be
announced to the public.
It involved reviewing immune therapy
proposals made by 27 teams of investigators. The second phase required a trip to
Philadelphia where the 4 finalists presented in person. This
allowed committee members to ask questions of the team leaders
and then to discuss the strengths and weaknesses without the
candidates present. We were given specific guidance on how
to weigh the strengths and weaknesses of the protocols, such as
innovation and the potential of the concept and team to
translate their ideas into meaningful clinical benefit in the
So which is more
important, the apple or the olive tree?
Similar to many
of OUR treatment decisions (that we make with the help of our
trained physicians) we canít know before-hand which approach
will bear the most fruit - so there is no clear cut right
answer. The proposals inspired a spirited
debate. The final vote was a VERY close call.
The news will be exciting.
Comments or Questions?
In this topic I will share impressions about a
renewed enthusiasm for immune therapy - based not on theory, but on
unexpected results in clinical trials in cancers that were not
expected to be immunogenic - responsive to vaccine and other
More to come.
Comments or Questions?
Regarding Giving Our Consent to Go into a Trial
In this topic I will share notes on the
informed choice process and the consent document - that will be of
interest to patients who are considering a clinical trial.
Did you know that:
The informed consent
document should focus on how the study is different
from regular care.
We have the option to go
off the study for any reason, such as
the study protocol isn't helping much, or the toxicities are
too much, or to take advantage of the response - as a
"bridge" to transplant. Or just our preference.
The informed consent document is not a contract. The
decision to stay or go is based on what is best for the
individual patient. The science is second.