The integration of electronic patient-reported outcomes and electronic clinical outcome assessments into routine cancer care can reduce the burden of data collection.

1. 10 ICT l May 2018
Optimising Outcomes
The integration of electronic patient-reported outcomes and electronic
clinical outcome assessments into routine cancer care can reduce the
burden of data collection
A patient-reported outcome (PRO) is a measurement based on
a report that comes from the patient (ie, study subject) about
the status of their health condition without amendment or
interpretation of the report by a clinician or anyone else. A PRO
can be measured by self-report or interview, provided that the
interviewer records only the patient’s response. Symptoms
or other unobservable concepts known only to the patient
(eg, pain severity or nausea) can only be measured by PRO
measures. PROs can also assess the patient perspective on
functioning or activities that may also be observable by
others, such as quality of life, time to pain progression,
and time to deterioration of physical symptoms.
In 2016, the American Society of Clinical Oncology (ASCO)
reported the FDA indicated that benefits in PROs can be the
basis for full drug approval (1). While this is true and PROs
are clearly the best way to collect patient data in clinical
trials, the American Medical Association points out that
other challenges exist that many oncology studies struggle
to overcome: small patient numbers, very sick or terminally
ill patients, high failure rates, and single-arm studies unique
to the development of new therapies in oncology (2).
For this reason, careful thought must go into designing
and implementing PRO measures in the oncology
clinical trial setting (3).
Traditional Paper Data Collection
Today, patients and site teams experience many limitations
when using paper to collect data during a clinical trial.
Site Challenges
Most oncology trials are still completed through site
visits that are increasingly admin-heavy as the number
of tasks in study protocols continues to grow. Some of
these tasks associated with site visits in an oncology
trial include busy visit schedules, tracking patient and
pain symptoms, concomitant medication (conmed)
tracking, and complex protocols. These tasks – in addition
to PRO data collection – cause huge burden for sites and
can lead to poor data collection.
Patient Challenges
Cancer patients that are in a great deal of pain are often
unable to attend site visits and find it difficult to report their
data. This leaves sites with non-performing patients or those
that do not provide all their health data on a regular basis,
creating confusion and leaving sponsors with uncertainty
around the treatment’s efficacy. Other challenges that
patients experience include:
• Strenuous travel to sites, which sometimes requires
long hours in a vehicle
• Failure to keep track of their numerous medication
and treatments
• Inability to attend a site visit/missed site visits that
require rescheduling and the subject to complete
questionnaires again
• Attending site visits may become too demanding if
patients become seriously ill, so assistance for completing
questionnaires and participating in the trial is required
ICT Oncology Clinical Trials
Katie Garner at
CRF Health
Image:©istock

2. www.samedanltd.com l ICT 11
These issues make completing trial questionnaires on paper
difficult for patients.
Adverse Events
Reporting adverse events and concomitant medication are
both important in an oncology trial. Because oncology patients
are typically very ill and experiencing significant symptoms
because of their disease and treatments, it is important that
any adverse events are identified and recorded. If the adverse
event happens at home, in between site visits, or is perceived
as a natural side effect of the patient’s condition, it could go
unrecorded, meaning that data could be excluded from the
trial. Considering conmed usage during a trial is necessary as
it can provide symptom relief that many cancer patients desire.
Tracking these medications during a clinical trial can be as
important as tracking the treatment being studied. Asking a
patient to write down the supplemental medications they take
can be difficult; they may not always remember what they take,
how often they take it, or its official name (different countries
sometimes call the same medicines by different names).
Traditionally, this has been recorded in an electronic data
system by the investigator, which means that the patient
is asked about concomitant medication during site visits.
Patients can find remembering what medication they took
quite difficult by the time of their next site visit, which can
be weeks after medication intake. These struggles clearly
lead to missed data and incorrect information.
Post-Progression Studies Challenges
Post-progression studies are defined as visits or contact
following completion of treatment, surgery, radiotherapy, or
chemotherapy. They are usually an extension or sister study
of an original trial. An increase in these follow-up studies make
it an item that teams must add to their list of considerations
when preparing for an oncology clinical trial. Often post-
progression studies involve the same questionnaire from
the main study. During this time, patients usually stop taking
the medication or begin taking an alternative medication. If a
patient is close to relapse, they may begin taking many drugs,
which can make it difficult for sponsors to obtain clean data of
the quality that regulators are looking for.
Electronic Clinical Outcome Assessments (eCOA)
According to the EMA, electronic data capture methods may
offer more convenience to some patients and increase data
quality, reduce missing data (allowing automatic reminders to
be sent), and potentially lower the number of data entry errors (3).
eCOA solutions can improve data quality in several ways during
oncology trials for patients, site staff, sponsors, and regulators.
Using a digital technology – such as handheld devices, tablets,
and the web – makes reporting data and tracking the effects of
a therapy easier than ever before.
Site Benefits
With so many patients, visits, and different schedules of
administration, eCOA solutions provide sites with the tools
and resources they need to reduce the administrative burden
of managing patients. For example, eCOA solutions enable
sites to schedule patient visits and automatically send
reminders to alert patients about upcoming visits. eCOA
solutions also empower sites to monitor patient compliance
to the protocol and track patient pain, symptoms, and
questionnaires all from one system where information for
each trial participant is stored. Finally, when the patient arrives
for their visit, eCOA solutions present the protocol-defined
questionnaire for that visit in the correct order so that the
site does not need to worry if they have the right version or
incorrect patient information. These tools drastically reduce
administrative time and effort by automating the data
collection process.
Reporting Benefits
Adverse event reporting can interpret adverse event data
from such questionnaires as the PRO-CTCAE. PRO-CTCAE
– a PRO measurement system developed to evaluate
symptomatic toxicity in patients on cancer clinical trials – can
be incorporated into the eCOA solution to make reporting
adverse events simple (4). With clinicians often failing to
report adverse events, growing evidence suggests that these
events are best captured directly from patients (5). eCOA
solutions support this with their ability to capture symptom
data from which the investigator can interpret adverse events.
eCOA solutions also support proper conmed capturing by
offering a predefined, personalised list of medications to
choose from, as well as the ability to nickname medications
for easier patient tracking. Collecting this information on an
eDiary alongside other study questionnaires means that the
patient can report conmed intake on the same day, resulting
in more accurate and reliable data.
Post-Progression Studies Benefits
With regulators driving sponsors to include post-progression/
follow-up periods in their oncology trials, eCOA solutions can
help reduce the burden on patients by remotely collecting
data as site visits become less frequent. The key to keeping
compliance high in this phase of the study is to deploy a flexible
solution. The many different modalities within eCOA can help
to provide this. Options sponsors can deploy include patients:
Regulators strongly favour
including the patient perspective
in oncology studies.This leads to more
post-progression and follow-up data,
which requires higher compliance

3. • Complete questionnaires at home using a provisioned
device to remind them when to report and guide them
through collecting data at home
• Complete questionnaires at home using a web diary
on a range of devices
• Complete questionnaires at home using an app on
their own device to remind them when to report via
an SMS message
• Come to the site to complete their questionnaires.
If they cannot make it to the site, a clinician can
transcribe their responses on a tablet device at
the site. This tasks the sites with ensuring data is
collected from the patient
The most appropriate method will depend on the
needs of the study, but sponsors have many options
to collect data without increasing patient burden
when using eCOA.
Patient and Caregiver Benefits
Patient-centric focus is one of the biggest benefits
eCOA solutions provide. Patients who become too sick
to complete the questionnaire at site visits can stay on
the study because eCOA supports:
• Rescheduling site visits to provide flexibility for patients
who may not be feeling well
• Re-activating incomplete or interrupted visits so that
patients can pick up where they left off
• Adding unscheduled visits for patients who may
need additional time at the site due to a change
in their diagnosis
• Extending data entry windows to accommodate
the patient
• Implementing a caregiver role to maintain data
collection without adding burden to the patient
Cancer patients that are very ill, but still want to participate
in clinical trials, have the option to elect a caregiver role on
their eCOA device. This allows the caregiver to input data
on behalf of the patient, supporting them throughout their
journey using observer-reported outcomes. On-device
training is provided to help caregivers feel comfortable
with the process and sustains compliance by ensuring
the data is reported regularly per the study protocol.
Looking Forward
Research suggests that 20% of oncology trials do not
recruit enough participants, and one in five cancer
trials fail due to lack of patient enrolment (6). Studies
also demonstrate that 97% of patients with cancer
do not participate in clinical trials and 60% of sites are
labelled ‘nonperforming’ during oncology studies (7-8).
Solutions are clearly needed to reduce the burden on
patients in clinical trials.
According to ASCO, “in multiple prospective studies,
integrating ePROs into routine cancer care has
improved patient-clinician communication, patient
satisfaction, symptom management and control,
and quality of life. Nurses find symptom email
alerts to be useful and actionable. Recent data
have found reductions in emergency room visits,
longer tolerability of chemotherapy, and improved
survival. This evidence of benefits has led to growing
interest in this approach” (1).
Regulators strongly favour including the patient
perspective in oncology studies. This leads to more
post-progression and follow-up data, which requires
higher compliance. eCOA solutions support this by
minimising the potential risks and reducing the burden
of data collection in oncology trials. eCOA solutions
make it easy to capture PRO from anywhere in the
world and in real time. By meeting the ALCOA standard
(attributable, legible, contemporaneous, original,
accurate) in a way that paper cannot, eCOA solutions
contribute to higher compliance.
References
1. Visit: www.am.asco.org/daily-news/rise-patient-reported-
outcomes-oncology
2. Visit: jamanetwork.com/journals/jamaoncology/fullarticle/2250350
3. Visit: www.ema.europa.eu/docs/en_GB/document_library/
Other/2016/04/WC500205159.pdf
4. Visit: healthcaredelivery.cancer.gov/pro-ctcae/measurement.html
5. Visit: www.focr.org/sites/default/files/FINAL%20PRO-CTCAE%20
pre-conference%20draft.pdf
6. Visit: www.fredhutch.org/en/news/center-news/2015/12/one-
in-five-cancer-clinical-trials-fizzle-fred-hutch.html
7. Visit: www.forbes.com/sites/judystone/2015/01/06/how-can-we-
encourage-participation-in-clinical-trials/#378d13fb6dd5
8. Visit: www.covance.com/content/dam/covance/assetLibrary/
infographics/Xcellerate%20Operational%20Infographic-2014.pdf
Katie Garner is Therapeutic Areas Advisor
at CRF Health. She is responsible for
providing specific therapeutic advice
and supporting the therapeutic, sales,
marketing and product development
teams. Previously, Katie worked as a
Project Manager for a Health Outcomes
Consultancy and at the NHS Purchasing and Supply
Agencies Centre for evidence-based purchasing. She
also worked for the Medicine and Healthcare Products
Regulatory Agency as a Senior Medical Device Specialist
where she was responsible for the safety and regulation of
in vitro diagnostic and contraceptive medical devices.
Email: hello@crfhealth.com
About the author
12 ICT l www.samedanltd.com