Download EDC 2001: a (pharma) space odyssey

DRUG DEVELOPMENT
EDC 2001:
a (pharma) space
odyssey
As the pharmaceutical industry moves towards the merging of old economy
stability with new economy innovation, technology can finally be expected to
make its mark on the drug development process.
Brian Chadwick and Scott Grisanti, eResearchTechnology Inc
eBusiness and
eCommerce can
represent both
creative and
destructive
forces - and
they have the
potential to
change just
about everything we do
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A
ccording to R&D Directions, pharmaceutical
companies have been slow to adopt
automation technologies (1). It is estimated that the pharmaceutical industry spends 4-6%
of company sales on information technology; this
pales in comparison with the 8-10% that companies in other information-intensive industries
spend. The perspective that the pharmaceutical
industry should or must improve the overall drug
development process - because it takes too long and
is too expensive - is shared by most industry executives.
But what form should these improvements take?
Are they strategic or tactical? Should the focus be
on technology or process? Should the technology
involve one-off solutions that bring incremental
value, or should companies aim for the "Holy
Grail" - the "end-to-end" solution? But what end
and to what end? And where in the new drug development chain should pharmaceutical companies
start to experiment with innovative solutions - and
when?
As easy as some observers believe it is to answer
these questions, it is easier still to underestimate
how difficult it is to change the way that the
pharmaceutical industry has always done business it may well take a lot more time and effort than
people realise.
Regardless of such opinions, it appears that
change - while moving slowly - is upon us. There
is an increasing interest by virtually every company
involved in the drug development process in
technology solutions and the Internet. There is
also a growing awareness and acknowledgment
amongst industry executives, as well as "grass roots"
Innovations in Pharmaceutical Technology
DRUG DEVELOPMENT
clinical research professionals, that technology
innovation can make a positive difference to the
drug development process.
Andersen Consulting recently reported the
results of a survey of 50 R&D executives from large
pharmaceutical companies (2). More than half of
the respondents agreed that new technologies were
fundamentally changing R&D processes; 86%
thought these technologies would have a great
impact in the near future, and 56% indicated that
there was already a high level of urgency within
their organisations to adopt new technologies.
The Association of Clinical Research
Professionals (ACRP) is one of the largest
organisations of clinical research personnel with
around 15,000 members. In a recent annual
survey - conducted in Summer 2000 and involving
2,300 respondents (3) - 66% of sites, 60% of
clinical research organisations (CROs) and
approximately 50% of sponsors expected to adopt
electronic CRFs within the next two years. While
current use of remote data entry (electronic data
capture, EDC) systems is still rather modest, a
much greater acceptance of EDC is anticipated.
Nearly half of respondents expected to gather and
disseminate clinical data over the Web within the
next two years. The association commented:
"When ACRP reviews data from its members
indicating that sites project more than a 200%
increase in Internet use for patient recruitment in a
two-year time-frame, and CROs expect a four-fold
increase in the use of electronic data capture in this
same time period, the Association must conclude
that rapid change is afoot."
In an address to the Executive Club of Chicago
in September 2000, Miles D White, CEO of
Abbott Laboratories stated: "Yes, the Internet is
among the most powerful transformational forces
we've seen in business. Yes, many traditional
companies have awakened relatively late to the
potential and the demands of eBusiness. And, yes,
significant barriers remain before eBusiness
becomes a truly integral part of the way most
established companies plan and run their
operations. But where the prevailing wisdom got it
wrong is to suggest that the innovators of these new
technologies - the dot-coms and the eCommerce
first movers - would be the only companies to
thrive in this new economy".
As we emerge from the dot-com phenomenon,
and as the "technology revolution" of the late
nineties becomes the "technology evolution" of the
new millennium, the potential of "old-line"
companies - including the major pharmaceutical
companies - is re-emerging due to some basic "old
economy" advantages. Their business models have
been tested over time; their customer relationships
are strong and they have reliable revenue streams,
proven credibility and tested brand names. While
Innovations in Pharmaceutical Technology
the pharmaceutical industry may indeed be slower
than some to adopt technology innovation, maybe
in the longer term this conservative approach will
prove a winning strategy.
Change - the technology
lessons learned
Since clinical development is the most costly and
critical factor in maintaining the pharmaceutical
industry's premiere position as regards total
shareholder return, it would also seem to be the
most likely target for technology innovation - but,
to date, this has not been the case. eBusiness
technologies are currently being used to transform
the buy and sell side of the drug development
supply chain. eBusiness and eCommerce can
represent both creative and destructive forces - and
they have the potential to change just about
everything we do. They change established
relationships between buyers and sellers; they
confound traditional pricing models and they alter
established supply chain processes.
Miles D White has suggested that in order to be
a part of the emerging business model - namely, the
reconstruction process that is the synthesis between
old economy business and new economy
innovation - "companies must be willing to be a
part of the deconstruction process as well".
Change certainly seems to be upon us. The
pharmaceutical industry will evaluate technology
innovation to improve operational efficiencies,
increase the speed and effectiveness of R&D
activities, and enhance the total experience and
relationship that customers have with suppliers.
And pharmaceutical companies can be expected to
learn from the "buy and sell" experience, to
continue to observe the ongoing dot-com
phenomenon and to scrutinise early forays into
electronic solutions for drug development. This
change - and the opportunity that surrounds
it - therefore comes with a lot of yellow caution
flags. It is incumbent upon the change agents in
the industry - the technology solution providers
and the contract service vendors - to approach this
change with care. They should introduce such
change into those areas where it is most likely to
produce benefit, and deploy user-friendly and
cost-sensitive technology applications that bring
clear value.
There is ...
a growing
awareness and
acknowledgment amongst
industry
executives, as
well as "grass
roots" clinical
research
professionals,
that technology
innovation can
make a positive
difference to
the drug
development
process
The impact of new technology
To measure value, it is critical for pharmaceutical
companies to define the practical, probable and
possible changes that technology will bring to the
drug development process. Until now, there has
been little success in managing expectations of the
likely impact of technology on drug development.
It is important to start with small doses; however,
in light of the careful and conservative approach
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DRUG DEVELOPMENT
While the
pharmaceutical
industry may
indeed be
slower than
some to adopt
technology
innovation,
maybe in the
longer term this
conservative
approach will
prove a winning
strategy
that will no doubt persist, the pharmaceutical
industry must resist the perpetual piloting
syndrome that has been evident in recent years.
The industry must find a balance between the
staunch technology conservatism of the past, and
the opportunities presented by the "new
economy". If expectations are realisable and the
perspective is evolutionary - not revolutionary then there is great opportunity to succeed.
Points of difficulty and the metrics for success
must be identified. When piloting technology
applications, the likelihood for success should be
good in order to create positive momentum. The
objective of the pilot needs to be changed from
the "stress test" to the "best test" for effective
evaluation; there needs to be a commitment to use
technology - rather than an effort to prove that the
technology doesn't work. There must be an
appreciation of the learning curve - there is virtually
no technology solution that can be deployed
without some degree of patience and pain! Parts of
the process need to change before the entire process
can change. There needs to be a plan that reflects
the reality of evolutionary change - incremental
value first and integrated solutions to follow.
Maybe then, the pharmaceutical industry will be in
a position to implement end-to-end solutions.
Drug discovery groups at large are dabbling
with some very innovative technology. High
throughput screening (HTS), combinatorial
chemistry, computer modelling and simulation,
and transgenic animal models are examples of
advanced technology solutions that are bringing
incremental value to the discovery and non-clinical
phases of drug development. Marketing groups are
experimenting with and gaining positive advantage
from using the Web to create '"communities of
interest" around therapeutic categories or specific
products. The electronic regulatory submission
(ERS) is rapidly becoming the preferred method of
application to the FDA.
In the clinical phases of drug development,
there are examples of successful patient recruitment
efforts through the Internet. Safety reporting and
trials management applications are gradually
finding their way into the process. Collaborative
workspace services have received attention recently
for idea collaboration and secure document
distribution. Online investigators' meetings
(synchronised learning) and self-paced learning
(asynchronous learning) are finding their place
(especially in light of 21 CFR). But what about
electronic data capture (EDC)?
Electronic Data Capture
Electronic data capture is an intriguing subject. It
is the year 2001 and EDC has already travelled the
path of a 15-year odyssey. Intuitively, EDC has
always made sense - but, practically, it is used in
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only a small percentage of clinical trials. There are
a number of reasons for this. EDC is a complex
technology, there are workflow issues, and there
has been no compelling solution to date that
effectively links EDC into the enterprise clinical
trials environment. But it is clear that collecting
and cleaning clinical trial data through paper-based
methodologies is an area of considerable pain and
substantial inefficiency. Clinical trials are the most
expensive and the most critical area of the drug
development process. If there is to be significant
improvement in the speed and capacity of drug
development, then it must happen in the trial
phase.
EDC may well have been ahead of its time.
Even though, 15 years ago or so, it may have
seemed that the trial phase was the right place to
introduce technology, with hindsight, it may not
have been the most appropriate place to start.
Maybe EDC was too revolutionary and not
evolutionary enough. We need to draw a deep
breath after spending so much time trying to
shoehorn EDC into a paradigm that has so far
resisted it. It might just be that today, as just one
part of an evolving technology paradigm, EDC will
be a better fit. But to be that "better fit", EDC
applications must address the "mixed-mode"
reality - in any clinical trial there are bound to be
sites that for one reason or another will not be able
to use the technology. EDC solutions must also
support paper-based data entry.
The evolution of computing has moved from
the mainframe era (which was vendor driven), to
the client server era (which was technology driven),
to the Internet/information era which is upon us
now and is clearly user (customer) driven. It is not
about technology or process - it is not even about
technology and process. It is about people, and
how technology and process will better serve them
to enhance their ability to do things.
EDC has demonstrated incremental value. In a
recent article (4), this incremental value was
referred to as a "glimmer of hope", where in some
cases EDC facilitated the "freezing" or "locking" of
a clinical trial database within days after the last
patient's last visit. This is in sharp contrast to the
3, 6 or even 18 months it can take when data
collection and data correction processes are
paper-based. Still, EDC technology has yet to
achieve widespread acceptance.
In the light of current experience with other
incremental technology applications, maybe as
EDC is reintroduced into the process as one part of
a more comprehensive technology solution, then it
will be better received. This may prove especially
true for EDC applications that support a variety of
data entry methodologies such as online, off-line,
paper-based double key, optical and intelligent
character recognition (OCR and ICR), as well as
Innovations in Pharmaceutical Technology
DRUG DEVELOPMENT
multiple discrepancy resolution processes. Maybe
EDC is starting to make sense to more people.
The combination of multiple incremental
applications may well become the solution, where
the value proposition better addresses the various
needs of the different constituents.
3. The Monitor, ACRP White Paper on the
Future - Where we are and where we're going.
Summer 2000, Volume 14, Issue 2, 17-32.
4. Pharmaceutical Visions. To "e" or not to "e",
Spring 1999, 12-16.
Conclusion
Suddenly, as the dust settles, there is available the
clinical trial Website; it has a digital dashboard
interface to facilitate ad hoc reporting. There exists
the opportunity to choose - in an à la carte fashion
- integrated functions and features such as:
•
news and views,
•
online investigator recruitment,
•
synchronous (and archived) investigators'
meetings,
•
secure, rapid document exchange,
•
Internet-based patient recruitment,
•
Web-based training,
•
safety reporting,
•
trials management,
•
clinical data entry, and
•
remote data management.
Whether the perspective is incremental value,
integrated applications and/or the "Holy Grail" of
the end-to-end solution, change is upon us.
Within the next couple of years, as the pharmaceutical industry moves towards the merging of old
economy stability with new economy innovation,
we can expect technology to finally make its mark
on the drug development process.
References
1. R&D Directions, eDevelopment and the
Power of the Internet, November/December
2000, 52-58.
2. Andersen Consulting, R&D and the Internet:
Opportunities to Profit from Web-Enabled
Pharmaceutical Research & Development,
AC10002480, 2000.
Innovations in Pharmaceutical Technology
Brian Chadwick is a founding partner of eP2, a
consulting group focusing primarily on technology
and process solutions for clinical trials and drug
development. He is also a co-founder of a Web-based
training company called the ePharmaLearning
Project and is Technology Chair at the ACRP. Before
eP2, he was founder and CEO of TechniLogix (an
electronic data capture company), a co-founder and
general manager of Health & Sciences Research Inc,
HSRI (a mid-sized CRO), a CRA at Squibb, and a
clinical trials manager at the Albert Einstein College
of Medicine, where he also served on the IRB for three
years. Mr Chadwick serves on the advisory boards of
a CRO and an OSHA Compliance Company, is
often a speaker at professional meetings and has 36
publications covering both the science and business of
clinical research and technology solutions for the drug
development process.
The evolution
of computing
has moved from
the mainframe
era (which was
vendor driven),
to the client
server era
(which was
technology
driven), to the
Internet/information era
which is upon
us now and is
clearly user
(customer)
driven
Scott Grisanti is Senior Vice President of Business
Development at eRT where he is responsible for
managing the company's field sales organisation
with a focus on increasing synergy between eRT's
applications and diagnostics technology sales teams in
the US and abroad; he is also responsible for
establishing and managing key strategic alliances and
global marketing activities. Mr Grisanti joined eRT
from ClearCross Inc, a leading provider of global
commerce management solutions, where he served as
Area Vice-President of Sales and was responsible for
launch of the company's initial e-commerce products
and services. Prior to this, he was Director of Sales
for the supply chain execution application provider,
Metasys Inc, with responsibility for sales and
marketing efforts targeting the contract logistics
services marketplace. Before joining Metasys, he
served as Director of Workflow and COLD Business
Development for Axis-One Inc, where he also served
as a Director in the channel sales organisation.
Earlier, Mr Grisanti was Director of UNIX Product
Marketing for Information Builder Inc - providers of
the FOCUS 4GL and EDA/SQL middleware.
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