Productive Partnering –
The Next Stage in Patient
Recruitment for Clinical Trials
By Ide Mills
Patients, oncologists, and the industry as sponsors and oncologists. It is one of responsibilities and events that come
a whole benefit from having the broadest several reasons that contribute to the with clinical trial participation.
dearth of patients participating in Compounding the situation, patients
possible range of effective treatment op- oncologic trials. may not fully understand what a clin-
tions. The availability of these treatments ical trial is and why it is important.
In an effort to increase patient
depends upon successful patient recruit- Alternatively, some patients may not
recruitment in clinical trials, the role
want to risk receiving an investiga-
ment for clinical trials. Patient advocates, of the patient advocate is evolving to
tional medicine or placebo, and many
community oncologists, and study spon- help close the gaps between the oncol-
fear the daunting list of potential side
ogist/patient relationship as well as
sors each play a critical role in increasing the study sponsor/oncologist rela-
effects presented in the informed con-
patient recruitment. sent forms.
tionship. Moreover, recent initiatives
According to the American Cancer undertaken by study sponsors suggest The Center for Information
Society (ACS), the 5-year cancer sur- additional ways that help overcome and Study on Clinical Research
vival rate for patients was 66% in patient recruitment challenges early in Participation (CISCRP), a nonprofit
2003 compared with only 50% two the process. GlaxoSmithKline’s Tykerb organization dedicated to educating
decades ago. This is an impressive Evaluation After Chemotherapy the public, patients, medical/research
increase fueled largely by successful (TEACH) trial is a laudable example. communities, the media, and policy
clinical trials and the resultant novel makers about clinical research partici-
Addressing the Patient Recruitment Issue pation, reports in a study conducted
treatments. While community-based
On average, American adults read at in 2002 that 75% of survey respon-
oncologists are aware that clinical
or below a ninth-grade reading level dents distrusted information received
trials are essential to the develop-
(J Fam Pract. 1998;46:1). Combined from clinical research profession-
ment of new treatments, many are
with the physical and emotional als—a substantial increase over the
unaware of available clinical trials
effects of a cancer diagnosis, low 28% who responded that way in 1996.
for their eligible patients. This lack
health literacy makes it difficult Furthermore, many patients, espe-
of communication is not only a prob-
for patients to comprehend compli- cially those in oncology trials, report
lem between oncologists and their
cated study protocols as well as the that overly complex or burdensome
patients, but also between study
28 ONCOLOGY BUSINESS REVIEW • ONCBIZ.COM • NOVEMBER 2008
study protocols are a concern—treat- Enter the Patient Advocate be overwhelmed by the legal lan-
ment regimens are hard to follow, the Patient advocates are working guage contained in patient consent
procedures invasive, the additional proactively to address the patient forms. Simplifying the consent forms,
office visits inconvenient, and the side recruitment issue. Deborah Collyar, which in some cases are more than 20
effect monitoring cumbersome. President of Patient pages long and contain the required
Richard Michaelson, MD, Chief Advocates in legal language, is a challenging but
Medical Officer for Oncology at the Research (PAIR) and worthwhile goal. Says Collyar, patient
Cancer Center of a breast cancer sur- advocates “aren’t there to ‘sell’ clinical
Saint Barnabas in vivor works with trials, but [to] bring patients simple
New Jersey advo- organizations that choices with clear explanations.”
cates for “a concerted include the NCI, Likewise, community oncologists,
national effort to Deborah Collyar, ASCO, and CALGB’s who have direct access to patients
raise awareness of President of Committee on and understand the needs of spe-
Patient Advocates Advocacy, Research
the importance of in Research cific patient populations can also
Richard Michaelson, clinical trials so that
Commu nicat ions, be helpful in making clinical trials
MD, Chief Medical people will not be and Ethics (CARE), to help bring the more palatable to patients. Through
Officer for Oncology, learning about clini- patient perspective to the clinical trial events, such as ASCO’s Clinical Trials
Cancer Center process. According to Collyar, revamp-
of Saint Barnabas
cal trials when they Workshops, community oncologists
are first diagnosed ing the protocol development process and their teams are given tools to
with cancer, which is a fearful and will help find “new ways to conduct evaluate, integrate, and conduct clini-
emotional time.” Dr. Michealson also studies so they are more palatable to cal trials in their practices. This year’s
says, that “widening a trial’s eligibil- patients.” Collyar notes that “patients conference featured several workshops
ity criteria and simplifying informed want to participate in a clinical trial, on patient recruitment some focusing
consent forms to list likely side effects not be subjected to a clinical trial.” specifically on addressing patients’
but not every side effect that has ever According to patient advocates, reservations. cont. on pg 30 >>
been reported can facilitate participa- patients who are otherwise moti-
tion in clinical trials.” vated to enroll in clinical trials can
NOVEMBER 2008 • ONCBIZ.COM • ONCOLOGY BUSINESS REVIEW 29
Productive Partnering –
The Next Stage in Patient
Recruitment for Clinical Trials
Model for a Successful Patient apy. GSK used the following principles Once oncologists are aware of tri-
Recruitment Strategy and the results led to a successful als that may be suitable for patients,
Study sponsors wisely recognize patient recruitment process. they also need a more complete
that community oncologists are best understanding of those trials’ spe-
1) Informing physicians about clinical
suited to select the appropriate clini- cific research goals and enrollment
trial availability. Often, community
cal trial for patients. Tantamount to criteria. Trial-specific study kits that
oncologists are unaware of available
that selection, is knowing what tri- contain FAQ sheets about the phy-
clinical trials. According to a CISCRP
als are available, what the inclusion/ sician’s roles and responsibilities,
survey, 44% of patients surveyed
exclusion criteria are, and what is pocket-sized protocols, and flash
learned about clinical studies through
required of patients and physicians cards listing inclusion/exclusion crite-
the media, while only 14% learned
to participate. Communicating that ria, for example, can help oncologists
about trials from their physicians. Dr.
information to community oncolo- prescreen and enroll the most appro-
Michaelson confirms that “learning
gists, who then priate patients for these studies. In
about all of the available clinical trials
pass it on to their the TEACH trial, GSK provided oncol-
can be a real issue” and thus encour-
patients, is no small ogists with eligibility work sheets to
ages oncologists to spend time with
task and is largely prescreen patients.
drug reps to learn what’s new in the
the responsibility field and also to ask them about avail- 3) Reaching out early and often. GSK
of study sponsors. able clinical trials. partnered early on with private prac-
According to Julie tice physicians in local settings and
Maltzman, MD, 2) Providing clinical oncologists
Julie Maltzman, MD, many of their conversations involved
Director of Oncology Director of Oncology with immediate access to databases
details of the study protocol. The
Clinical Development Clinical Development of trials helps to increase patient
at GSK TEACH team met with community
at GSK, “it takes a enrollment. In an effort to increase
oncologists and listened to recruit-
Herculean effort to make a clinical awareness of available trials, many
ment challenges. This gave the team
trial happen and have relevance to study sponsors contract with com-
the opportunity to evaluate the study
clinical practice.” panies, such as EmergingMed (www.
protocol, anticipate recruitment chal-
EmergingMed.com). This navigational
A successful partnership between lenges, and then work directly with
database allows the patient to cre-
study sponsors and oncologists the community oncologists to over-
ate a profile and then finds—through
revolves around a robust communica- come any of the challenges. “Nobody
their database—any available trials
tion campaign. Dr. Maltzman oversaw can design a perfect study,” said Dr.
that match the patient’s specific can-
recruitment for the ongoing TEACH Maltzman. By collaborating with the
cer diagnosis, stage, and treatment
trial, which presented unique recruit- oncologists, GSK was able to design a
history.
ment challenges. The study examines study protocol that better facilitated
adjuvant treatment with lapatinib Other Web sites that provide patient recruitment.
(Tykerb®) in early-stage HER2 positive searchable databases of available tri-
4) Helping physicians talk with their
breast cancer patients who have suc- als include www.clinicaltrials.gov and
patients. Educating, enrolling, and
cessfully completed standard therapy. www.cancer.gov. Study sponsors, from
supporting patients in clinical tri-
Because these patients had already government agencies such as the NCI
als require considerable time and
been successfully treated, they were to pharmaceutical companies such as
resources from community oncolo-
less open to additional adjuvant ther- GSK, use the Web to increase aware-
gists. Some study sponsors provide
ness of clinical trial availability.
30 ONCOLOGY BUSINESS REVIEW • ONCBIZ.COM • NOVEMBER 2008
TakE hOld OF
yOuR iNduSTRy
tools that help oncologists and staff communicate
effectively with patients, which can maximize the oncol-
WiTh OBR daily.
ogists’ efforts and can enhance recruitment. Once an
oncologist (or a patient) has initiated a conversation
about a clinical trial, the oncologist must be able to
provide more information, including eligibility require-
ments, dosing regimen, and study procedures. One way Our FREE
to provide this information is with an enrollment kit
that oncologists can present to their patients. The kits oncology
give patients a chance to take the information home,
read it through, and come back to the oncologist for focused
more information.
E-NEWS
It is crucial that all enrollment kit elements follow
health literacy principles. Easy-to-comprehend mate- service.
rials enhance patients’ understanding of the clinical
trial process, which can allay any fears and make talk-
ing with physicians easier. According to Dr. Maltzman,
pamphlets about clinical trials are helpful but “there’s
no better tool than human contact. To be able to ver-
balize fears, anxieties, and hesitation or to identify the
positive parts of clinical trial participation, you need to
have a conversation.”
Working Together
Although the reasons to successful patient recruit-
ment are numerous, patient advocates, study sponsors,
and community oncologists are working to generate
awareness and improve communication. Through
patient advocacy organizations, educational Web sites,
and partnerships between study sponsors and commu- > delivered right to your inbox
nity oncologists, efforts are being made to raise the
public’s awareness about clinical trials and increase > Timely, comprehensive coverage of oncology news
and events
patient recruitment. As in all relationships, communica-
tion is key, perhaps no more critically than when > We monitor and link to all major media outlets
recruiting for an oncology clinical trial, which can pro- > Onco-Expertise: Our staff filters and prioritizes
duce life-saving or life-extending treatments. IM oncology news stories so you don’t have to
> Special features such as OBR Radar, webcasts,
Ide Mills, MSW, LCSW is a Senior VP at HealthEd Tumor Ticker™ Top 3 Winners & losers, blog entries,
Encore, a full-service marketing agency specializing in On-Conversations, and an oncology events calendar
educational marketing solutions for pharma, device, biotech, and health-
care companies. Ide can be contacted at i.mills@healthedencore.com. > Mobile version available
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