EDC Survey WP

Unveiling Technology’s Impact

How eClinical Technology Is
Impacting Investigator Sites
and Your Clinical Study

A Porter Research Report
Sponsored by OmniComm Systems Inc.

Contents

Overview.................................................................................................................................... 1
Trial Efficiency Decreases with Protocol Complexity ................................................................ 1
EDC Usage & Satisfaction .......................................................................................................... 5
EDC Preference.......................................................................................................................... 9
Reassessing How Technology Is Viewed ................................................................................. 10
References............................................................................................................................... 12

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Overview 10-year overall growth (2002-2012) in total

Clinical protocols that guide the research team’s procedures and work burden per protocol by
activities have increased in complexity, generating more phase.1
data than ever before. Complications have resulted as
sponsors and Contract Research Organizations (CROs)
set additional requirements that research teams must
accommodate into their daily trial workflow.

The growing burden placed by CROs and sponsors on
clinical site investigators and site staff include escalating
development time, difficulties in patient recruitment,
regulatory expectations and significant operational
hurdles. Additionally, site investigators are challenged
with clinical trial remuneration, technology tools,
protocol complexity, and sponsor demands.

These demands on trial resources often result in delays,
extending the duration of the study and increasing
stress on all program participants. The escalating
development time for trials has consequentially
lengthened patient involvement time, which makes trial
recruitment considerably more difficult for researchers.

Trial Efficiency Decreases with Protocol
Complexity

The complexity in clinical protocol design has
progressively increased for many reasons. These
include the trend for trials to focus more on chronic
diseases, where clinical endpoints have become more
difficult and time-consuming to measure and patient
populations have become more targeted. Also,
increasing competition between drug companies has
made it desirable to gather more data to help
differentiate their products within crowded markets.1

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6% The added complications to conduct clinical trials cause
longer study durations and increases in operational
of clinical trials completed costs within the R&D (Research and Development)
on time continuum. For example, it takes Pfizer about 12 years
for a potential new therapy to gain FDA approval for use
72% in patients. In this lengthy process, the clinical trial
work represents the most time-intensive and expensive
of clinical trials run over by part of R&D, accounting for approximately 45% to 75%
one month of the $1.2 billion average cost of bringing a new
therapy to market.2 Few trials are completed on
69% schedule. In fact, according to The Center for
Information & Study on Clinical Research Participation
of oncology trials increased (CISCRP), only about 6% of clinical trials are completed
duration from 23 months – on time, with the overwhelming majority (72%) running
39 months over schedule by at least a month.3

Investigator sites worldwide are struggling to stay on
track amid an ever-increasing number of clinical trials,
each with its unique complex protocol design. Certain
therapeutic areas, such as oncology, have been
especially susceptible to longer study durations.
Globally, oncology-focused trials are the most prevalent
in the life science industry. From 2002-2014, the
median duration timeline of a typical oncology clinical
trials has increased by 69%, from 23 months to 39
months, adding an additional 16 months on average to
complete studies. The extended study duration is
attributed to the increase in protocol complexity, trial
design, numerous endpoints, increased patient
enrollment, and longer treatment periods.4

These burgeoning study metrics generate an enormous
amount of data that must be collected, managed and
directed in the site environment. This requires site staff
to be proficient administrators in data management and
familiar with all technologies that are part of the trial
program. A trial can involve several diverse
technologies (e.g.; Electronic Data Capture [EDC],
Electronic Patient Report Outcome [ePRO], Interactive

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Web Response System [IWRS], and central 10 - 12
laboratories). Investigator sites must understand the
unique requirements for each trial, including the Clinical trial related software
equipment, technology and procedures used, as the applications used by
next patient examination may be part of a different investigator sites.
trial.5
3.5 EDC
On average, investigator sites use 10 to 12 software Systems
applications simultaneously to manage their clinical
studies, each with unique login instructions and Used by investigator
training. These eClinical tools can be a combination of site staff
applications: EDC, Clinical Trial Management System
(CTMS), an internet portal, or a tool built by the sponsor
or CRO. This means that researchers must be trained
on each system, which often has disparate functionality
to one another, increasing the difficulty of user
adoption.6

Maintaining multiple eClinical tools is a burden on the
currently overworked site staff, possibly causing
confusion and duplications in data capture and
management. A recent CenterWatch study, in
collaboration with the Association of Clinical Research
Professionals (ACRP), of global investigator sites found
that less than 10% of respondents believe that clinical
trial technology solutions provided by sponsors and
CROs are meeting their operating needs. They find the
technology incompatible with the existing trial design,
which causes performance inefficiencies within the
investigator site.7

One of the most adopted technologies is EDC, as it
forms the backbone of data collection and aggregation
for a clinical trial, and used in approximately 80% of
investigator sites. Porter Research (Atlanta, GA)
recently surveyed clinical research site investigators and
staff to globally to gauge their degree of satisfaction
and preference of EDC systems. Respondents used, on
average, 3.5 EDC systems during the past two years and

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Clinical Investigator Trend as high as 11 EDC systems. This multiple tool
management means juggling each tool’s login codes,
SOURCE: Tufts Center for the Study of Drug Development. training requirements, support requests, administrative
2009. Impact Report Jan/Feb; Current Investigator management, and data entry tasks as part of the daily
Landscape Poses a Growing Challenge for Sponsors workflow process. When responses were segregated by
geography of site locations outside of North America,
40% the usage average decreased to 3 EDC systems.

Investigators that do not re- Trials have been shifting to international investigator
enroll as an investigator sites for the past two decades. The reasons for the shift
are multi-faceted, but the more streamlined technology
usage typically correlates with shorter trial durations,
lower costs, and fewer data errors. These improved
trial outcomes at overseas investigator sites attract
more sponsor interest. The amount of clinical
investigators from North America has decreased since
1997, while the amount of investigators from Western
Europe and the rest of the world have been steadily
rising. The graph at the left illustrates the trend.

Conversely, more remote investigator site locations
pose challenges for sponsors and CROs to deploy
effective training and support. Onsite visits may be
financially unfeasible, and the differing time zones may
cause delays in solution support requests. Initially, it
could take more time for staff to become proficient
with newly introduced technology over investigator
sites that have a more accessible connection with their
technology resources.

The Tufts Center for the Study of Drug Development
reported that approximately 40% of investigators who
filed a Statement of Investigator Form 1572 from 2012
to 2013 opted not to re-enroll as an investigator. This
significant rate of investigator turnover highlights the
burden of managing complex trials that are accountable
for achieving study objectives and satisfying all
requirements related to sponsor needs, quality
assurance, and regulatory compliance.8

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EDC Usage & Satisfaction 3

Investigator sites most commonly use EDC technology Week lag for EDC data entry
for gathering and managing data during clinical trials.
However, individual EDC brands differ significantly from
one another in numerous ways, from interface design to
functionality and performance. Therefore, even a
multi-EDC environment does not offer a streamlined
process for data management by.

EDC usage, and its innate ability to speed up the flow of
data within in the site, is often not realized due to
human-induced delays in this fragmented data
management environment. Managing multiple
technology solutions typically causes a lag time of about
three weeks from a patient visit to when data is actually
entered into the EDC.5

Each EDC solution has to be set-up in relation to the full
scope of the trial design to maintain data integrity in
accordance with industry standards and regulatory
compliance. The configuration must address the
numerous components of data management, including
setting parameters for data entry and data tracking
guidelines, quality control measures, SAE (serious
adverse event) reconciliation guidelines, discrepancy
management, data transfer/extraction, and database
locking guidelines.

“Bringing an outside technology into a trial environment
without the input from the clinical site team is very
short-sighted and can undermine clinical work,” stated
Christine Pierre, RN, president of Society for Clinical
Research Sites (SCRS). SCRS is an advocacy group
dedicated to the community of clinical research sites.
“Researchers are running a clinical-learning site, not a
technology-driven one. Technology should conform to
the clinical study, and not the other way around, of

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orth merica trying to make the clinical work fit a supplied eClinical
uro e tool."
est o orld
“As an industry, we need to start thinking more
dynamically about how technology is applied to the
overall trial design. EDC systems have become a
mainstay for data management in trials, serving as a
hub of connectivity to bring all information together,”
she continued. “This data capture technology has
evolved very rapidly, but industry adoption of these
dynamic changes has not kept pace.”

Sites with a demonstrated EDC success rate, through
streamlined usage, would encourage participating
sponsors to adhere to the established technology set-up
instead of complicating the process with additional
tools.

OmniComm Systems, Inc. (Fort Lauderdale, FL)
commissioned the previously mentioned Porter
Research survey sent earlier this year to site
investigators worldwide to gauge their level of
experience, satisfaction, and preference for EDC
systems. The sponsor-anonymous online survey was
designed to get EDC site users to provide unbiased
responses about the EDC systems they use.

Over 850 site researchers took part in the survey, with
respondents representing more than 200 countries.
The majority (59%) of survey participants were located
in the U.S. Based upon job function, 66% of
respondents were study coordinators/nurse, 24%
investigators and the remainder serving in various roles.

Site investigators were asked what motivated their
solution preferences and to identify their most highly-
valued priorities related to EDC usage. Survey
participants had the opportunity to select their

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preferred EDC brand, pertaining to their experience,
and then rate the different areas of satisfaction.

Survey respondents selected the following as their most
important criteria in an EDC system:

1) Ease of data entry
2) Easy to login and navigate
3) Overall user system familiarity
4) Overall user-friendliness
5) Easy to answer queries

These criteria have a direct impact on timely data entry,
improved data quality, increased protocol compliance,
and a higher level in site user satisfaction.

Survey respondents were also asked to quantify the
usage with each EDC application in terms of the number
of studies per system in the past years. The findings
indicate the study volume using Medidata® and Oracle®
EDC solutions had a nearly equal market size of 38% and
35%, respectively. OmniComm TrialMaster EDC was
third at 8%, followed by BioClinica® Express (6%). The
remaining EDC systems represented a 3% or fewer
shares of the 4,200+ studies that were conducted
during the last two years.

According to survey results, ease of use, system
performance and support are the three primary areas
that affect a site’s EDC level of satisfaction and
performance.

Ease of use relates to easy to answer queries, enter
data, login, and navigate and how intuitive the user
interface is to use. System performance includes the
lack of wait times for page turns and page refresh and
the general availability of the system with no down
time. System support involves the responsiveness and

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competence of help desk support and the quality and
availability of training and eLearning.

Among these three top-tier categories, site researchers
rated their satisfaction levels for the dozen most
popular EDC system brands. Below is an overview of
how TrialMaster compared against other combined
brands:

Ease of Use Performance Support

Other EDC Systems 91% 72% 63%
OmniComm TrialMaster EDC 93 ?+ ?+ 3 ?+10

Overall, participants indicated the importance of having
an EDC solution that aligns with the clinical workflow, in
terms of a user-friendly design and consistent
functionality. Their goal was getting data into the EDC
system earlier and reducing the documented lag in data
entry. They also expressed the need for more solution
training and support services to help address data
capture issues that arise during the lifecycle of the
clinical trial.

High Satisfaction Rating – Performance and support have taken on extra
Good Performance/No System Wait Time importance. The demand on sites to work with
Percent of Survey Respondents numerous EDC and eClinical systems decreases
productivity and increases data entry time and
frustration. EDC systems have matured and perfected
their user interfaces as evidenced by the high
percentage of satisfied site users. However, EDC system
performance and support received less than remarkable
satisfaction rates. High performant EDC systems deploy
each study to a unique database that dramatically
increases performance. The 6% satisfaction increase for
OmniComm TrialMaster is evident of that, unlike other
EDC systems.

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Help desk and the training quality and availability are High Satisfaction Rating –
components of any end user support system. The Help Desk Support
percent of highly satisfied site users for these are Percent of Survey Respondents
indicated to the right. Organizations with in-house
dedicated help desk support prevail over those out-
sourcing help desk. Illustrative is that corporate size
does not equate with a high degree of site user
satisfaction for either help desk or training.

EDC Preference High Satisfaction Rating –
Quality & Availability of Training/eLearning
When determining overall preference of an EDC system, Percent of Survey Respondents
it is important to remove the effects of familiarity bias.
Therefore, only survey respondents with the same level
of experience are used. For example, the same
respondent used OmniComm TrialMaster EDC and
Medidata Rave for three studies during the past two
years.

Familiarity bias occurs when the buyer is predisposed
toward the ‘ amiliar’ com ared to an im artial selection
derived from empirical data. How does the familiarity
bias influence the selection of which EDC system to
use? The main problem is that when a CRO or sponsor
selects a familiar (or perceived to be familiar) EDC
system, they underestimate the amount of risk in the
investment. As a result, they do not take the right steps
of reducing risk. Not only is familiarity a flawed guide to
what is beneficial, it can lead to choices that actually
exacerbate stress – especially for investigator sites.

Preference was determined for the top three EDC
systems described earlier – Medidata Rave, Oracle
Inform® and Oracle Remote Data Capture (RDC), and
OmniComm TrialMaster EDC. Twenty-eight
respondents had the same level of experience with
OmniComm TrialMaster EDC and Medidata Rave.

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Their experience was across 146 clinical studies, of
which 57% of respondents preferred OmniComm
TrialMaster EDC to 43% for Medidata Rave, an
approximate 8:2 ratio. Thirty-one respondents had the
same level of experience with Oracle Inform and
OmniComm TrialMaster EDC across 136 studies.
Respondents preferred Oracle Inform to OmniComm
TrialMaster EDC 52% and 48%, respectively, an almost
equivalent ratio of 5:5. Twenty-nine respondents
utilized OmniComm TrialMaster EDC and Oracle RDC for
112 studies. es ondents’ re erence was mni omm
TrialMaster EDC – 79% - and Oracle RDC – 21%: an
approximate 8:2 ratio.

Reassessing How Technology Is Viewed

Data capture is critical for clinical trial success in order
to bring new therapies and drugs to the market.
Investigator sites need EDC technology that improves
data quality and compliance, and helps alleviate the
challenges and work burdens that are resent in today’s
studies. EDC user satisfaction should be taken into
account, as sites review their overall technology usage
and assess its value toward study completion.

There is evidence that investigator sites staying current
with the latest EDC upgrades and technological
advancements tends to correlate with higher user
satisfaction levels, particularly in the areas of ease of
use, performance and support. Improving the user
experience for site staff can promote more active EDC
usage and, thereby, shorten the average three-week lag
time between patient visits and data entry. This
improved EDC usage causes fewer disruptions to the
clinical workflow and improves data quality.

Researchers would benefit by working with their
sponsors and their technology partners to focus on the
parameters of the trial, letting technology and

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training/support be evaluated in accordance to how
well it contributes to the efficiency of trial success.
Technology is not simply a commodity, but an end-to-
end comprehensive service requiring sufficient
flexibility to fit the unique dynamics of the trial work
taking place in a busy site environment. Technology
should streamline work processes, rather than add to
the administrative effort.
Sponsors can greatly contribute towards trial success by
understanding more about the data capture challenges
from the perspective of the research team. Viewing
technology as a tool, disconnected from the complex
trial environment, exacerbates data management
efficiency and can be counterproductive to the s
sponsors’ expectations.

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References
1. Getz, K. Int. J. Improving Protocol Design
Feasibility to Drive Drug Development
Economics and Performance. International
Journal of Environmental Research and Public
Health 2014, 11, 5069-5080
2. www.pfizer.com/research/clinical_trials/phases
_of_development
3. www.ciscrp.org/professional/facts_pat.html
4. Alsumidaie, M. and Shiemann, P. Why Are
Cancer Clinical Trials Increasing in Duration?
Applied Clinical Trials, August 31, 2015
5. Buckley, B. Identifying and Meeting the
Challenges of Clinical Trial at Investigator Sites.
Journal for Clinical Studies, Vol. 4:3
6. Getz, K. m hasizing ‘ olutions’ in e linical
Tools for Sites. Applied Clinical Trials, Vol. 25:6.
June 01, 2016
7. CenterWatch, 5/17/16,
https://www.centerwatch.com/press/pr-2016-
05-17.aspx
8. Getz, K., Lamerti, M. Global Site Landscape
Remains Highly Fragmented and Variable
Performance. Tufts Center for the Study of Drug
Development Impact Report, March/April
2013:15(3)

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