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Optimising eClinical
Figure 2: Please Rank the Top Three Technologies in Which Your Company Will Invest Over the Next 12 Months
Weighted number of votes
70
60
50
40
30
20
10
3rd Choice
2nd Choice
0
1st Choice
CTMS EDC Data Legacy eSub Virtual RFIDs
mining data patient
Future technologies
CTMS = clinical trials management system; EDC = electronic data capture, including electronic diaries and case report forms; data mining includes extraction and reporting tools; legacy data =
integration thereof, both structured and unstructured; eSub = structured electronic submissions; virtual patients = computational models; RFIDs – radio frequency identification tags to manage
the clinical supply chain.
Source: Insight Pharma Reports, March 2006. Contact: Mike Goodman, Editor-in-chief, mgoodman@healthtech.com
Offshoring, most notably in the Asia-Pacific region, can save costs – technologies, with the result that the drug development industry has been
particularly in expensive phase III trials. There are other advantages in a “slow-adopter” of new technology, says Dr Ron Fitzmartin, President-elect
terms of access to diverse and treatment-naïve patients (elaborated in the of the Drug Information Association (DIA) and Vice President of Informatics
Novakovskiy article), but with all advances there are new issues to and Knowledge Management at Daiichi Sankyo Pharma Development.
overcome such as legal and intellectual property (IP) problems,
understanding different national regulatory environments and standards As an illustration, he points out that the US Food and Drug Administration’s
of care, training study personnel and coping with ethical issues. (FDA) Critical Path Initiative and the European Medicines Agency’s (EMEA)
Roadmap both mention the slow uptake by pharmas of technologies that
Tellingly, more than three-quarters of CHI’s respondents had already have the potential to “move clinical trials to a different level”. Two of the
implemented EDC in clinical trials, or were planning to by 2009. EDC
equipment such as eCRFs and eDiaries were also popular tools in which
pharma will likely invest (see Figure 2).
EDC is not a solution unto itself.
The integration of EDC allows other
Davies from Bio-IT World elaborates: “The arrival of technologies such as
EDC have had a great impact in this regard (speeding up clinical trials), in
disruptive technologies, notably
large part because every day saved in clinical trials could translate to
adaptive trial designs, to become
US$1 million or more in drug development cost savings. But EDC is not a
much more commonly adopted...
solution unto itself. The integration of EDC allows other disruptive
technologies, notably adaptive trial designs, to become much more
commonly adopted across the leading pharmas.” main initiatives in the Critical Path are the use of biomarkers and adaptive trial
designs, neither of which can be realised without technology. “The FIREBIRD
Putting Into Practice initiative and the adoption of CDISC standards are just two examples that
There is a huge gulf between saying and doing, and implementing the show that the FDA wants to become an ‘eFDA’,” Fitzmartin adds.
eClinical vision takes more effort and planning than simply flicking a switch.
For instance, CDISC recommends that certain issues be considered during According to Fitzmartin, better drug development comes from improved
a technology selection process, including, among others: the hosting processes, which can be optimised by technology, but not controlled by
environment – in-house or externally hosted; user acceptance, promoting it. “The core competency of pharma development is pharmaceutical
flexibility and accessibility; user support, again whether provided in-house development, not information technology. So, pharma need to
or by a third party; regulatory requirements, e.g. 21 CFR 11; cost; and understand and leverage technology, but not to build it ab initio,” he
support for the standards (see the Lastic article for more information). opines. The bottom line is that, with Moore’s law dictating pace of
change, “pharma must be able to deploy new technology in six months
Partly for these reasons, companies are cautious of implementing new or fewer, otherwise the technology will have moved on”. ■
6 DATA MANAGEMENT IN PHARMACEUTICAL RESEARCH & DEVELOPMENT
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