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A Brief History and Look at the Future of Electronic Data Capture
Dr. Bill Gluck, Vice-President Clinical Knowledge
The clinical trials industry continues to look for opportunities
to effectively and efficiently manage data collected in
clinical trials to deliver meaningful treatments to those in
need. Electronic data capture (EDC) has traveled a long
road to acceptance within the pharmaceutical industry.
As technology advanced rapidly over the past 30+ years,
the use of an EDC tool within the industry has lagged
behind the innovation. The traditional method, the use of
paper forms and the processes to capture, review, query,
and report the results of clinical trials, are still used today
in almost 30% of active trials (Cahill).
The use of paper-based data collection systems, while
easy to learn and implement continue to have the same
shortcomings:
• Paper forms need to be developed and
completed across countries and languages,
which poses transcription and logistical
problems
• Legibility issues are noted
• The time between the completion and review of the forms to the generation of queries
(clarification/questions regarding the forms) are
delayed, typically several weeks or even months
• Multiple versions are made, thereby increasing
the possibility for inconsistencies in the paper
records
• The study participant’s medical status is not transparent, or at best delayed
In order to address some of these shortcomings, the
use of mainframe computers was introduced in the late
1970’s, particularly in the academic institutions equipped
to conduct clinical trials. ‘Dumb terminals’ were placed
near the clinical sites to allow for direct entry of data into
the mainframes. This soon proved to be a very limiting
methodology as well as a costly means to capture the
data, and the process still relied on the more traditional
paper-based approach to capture and handle the clinical
data.
In the 1980’s and 1990’s, remote data entry (RDE) was
introduced into the pharmaceutical industry. Personal
computers were provisioned at clinical sites, thereby
making them easier to scale and distribute when
compared to the mainframe terminal configurations.
Technology became more connected; a signal sent by
telephone line made the transfer of data easier. Floppy
disks and a smaller hard diskette were developed and
used to collect greater amounts of data which were easy
to transport.
RDE also allowed the doctor or clinical site staff to enter
the data directly into the computer, eliminating the need
for a third party to enter/transpose data from the paper
forms. In doing so, the RDE computer programs could
provide a first level of programmatic ‘checks’ on the data
entered. For example, dates and range values could be
flagged for verification before saving the data to the
computer and either connecting the computer to the
phone to transfer the data or write the data to a disk to
send to the sponsor.
In the 1990’s, Electronic Data Capture (EDC) became
the next generation of computer applications specifically
designed to address the needs of the pharmaceutical,
biotechnology, and medical device industries. Early
adopters were sponsoring companies with IT departments
who built their own applications. In the mid-to-late 1990’s,
specialized vendors such as DATATRAK began to introduce
applications in what we know today as commercial-offthe-shelf (COTS) solutions.
Since the early 2000’s, there has been rapid improvement
in the COTS applications available for companies to
use when conducting clinical trials. These applications
have grown to include aspects of the clinical trial that
exceed just the collecting and handling of the clinical
trial data. As there was a rapid growth in the number of
EDC applications, the industry also noted there was a
considerable amount of variability in how the data were
defined, handled, and transferred from one site to another,
and unless this was addressed, broad acceptance of EDC
throughout the industry and by the regulatory agencies
worldwide would be limited.
Clinical Data Interchange Standards
Consortium (CDISC)
In the late 1990’s a consortium of industry companies
collaborated and defined global standards aimed to
streamline clinical research. The mission of CDISC is “to
develop and support global, platform-independent data
standards that enable information system interoperability
to improve medical research and related areas of
healthcare.” (Cahill). Since its inception, CDISC and the
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standards that have been developed have gained broad
acceptance throughout the industry and have provided
a standard backbone upon which EDC has evolved.
With the level of acceptance spanning industry and now
regulatory agencies, CDISC standards have become
accepted as the global standard for the development and
implementation of not only EDC specific applications but
of those applications having a broader and more holistic
view of the eClinical environment, from trial planning to
regulatory submission and beyond.
Current EDC Landscape
Today, many EDC applications approach clinical trials
in a more holistic manner taking into account the
broad ‘eClinical’ landscape. In defining ‘eClinical’ as
encompassing the entire clinical process of data
collection, not only the trial-specific patient data but
that of third-party laboratory results, the use of coding
systems, safety systems, and clinical trial management
systems.
An estimated 70% of all active clinical trials are using EDC,
in some fashion. This indicates that the use of EDC has
gained acceptance throughout the industry. Regulatory
bodies, such as the FDA, have also embraced EDC via
the use of the CDISC standard. Guidelines and laws,
such as PUDFA IV Section 12 mandate that all new drug
submissions will need to comply with CDISC standards
by the year 2017, demonstrate how EDC has become
engrained into the fabric of the drug development process
and has replaced the paper process.
Regulatory agencies in the EU and Japan have also
implemented very specific regulations and guidelines. For
example, the Japanese FDA is considering the mandate
that all data submitted for agency review to be in CDISC
format by 2016. While this proposal is being seriously
considered, it may not come to fruition; however, it does
indicate that regulatory agencies worldwide are united in
ensuring clinical data standards are uniform and universal.
In some areas of the world however EDC acceptance
has lagged, particularly in China and India where their
drug development industries are still in development.
For example, in China most of the clinical trials are done
using paper forms. The regulatory oversight in China is
evolving rapidly and new guidelines on the use of data
standards, such as those developed through the CDISC
organization, are being defined. Soon, the landscape of
vendors in China will begin to change as many small
vendors who have not developed CFDA compliant EDC
applications will be forced out of business and compliant
applications will become prevalent.
Future of EDC
As we look to the future, EDC continues to evolve and
grow in scope and breadth in terms of capabilities. The
cornerstone of the eClinical industry, additional software
solutions have developed to complement EDC, including
CTMS, PRO, Imaging, and more. Technology, introduced
to the clinical trials industry through EDC, has created
more opportunities, and will require more standards to
achieve the full potential of efficiency made possible by
the evolution of technology.
With the growing use of electronic medical/health records
(EMR’s or EHR’s), there will be the need to introduce
standards similar to those defined by CDISC to assist
in normalizing data structures and providing guidelines
in the security of personal information. Additionally, as
these standards are put into place, the quality standard
of the data will also need to be defined and accepted
throughout the various key users of these data. With the
continued development of these standards, the use of
EMR’s will be a significant growth area in the coming
years.
The next evolution in EDC applications will leverage the
expanding power of technology to ‘virtualize’ the clinical
trial process. Some clinical trials might be able to be
conducted with minimal visits to a doctor’s office or clinic
and could potentially occur via real-time computer and
video feeds. Studies that use direct entries of clinical data
(eSource) are being conducted today and are another
rapidly evolving segment of the industry.
Many of the successful companies that provide EDC
applications to the industry struggle to move data into a
single repository in order to facilitate the easy access of
these data in the form of reports or computer searches
for information. Those companies with unified clinical
databases will have the advantage as there is no need to
move or manipulate these data into a single repository.
This advantage is also noted as a key feature by regulatory
agencies in their ability to review new drug applications as
approximately 45% of the time needed for a FDA review
is wasted in moving data (taken from comments made by
J. Woodcock CDISC Conference November 2012).
The EDC industry will continue to evolve, leveraging the
expanding power of technology to manage global clinical
trials and the related data in an effort to bring meaningful
treatment to those that need it.
Cahill, Dan. “Survey Reveals Technology Gap in Managing Clinical Trial
Documentation.” . PR Newswire, 09 Oct 2013. Web. 7 Apr 2014. <http://
www.prnewswire.com/news-releases/survey-reveals-technology-gap-inmanaging-clinical-trial-documentation-227049571.html>.
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