Intro_edit.qxp 4/6/07 5:25 pm Page 5
Introduction
Putting the ‘e’ in R&D
a report by
Michelle Grayson
Managing Editor, Medical Communications, Touch Briefings
eClinical is no longer just a buzz-word, but a business and scientific reality. efficient technologies to speed the flow of drugs into and through clinical
An eClinical trial is defined by the Clinical Data Interchange Standards trials. The cost of drug development is likely to soar to a staggering
Consortium (CDISC) as a study “in which primarily electronic processes are US$2 billion per IND [investigational new drug] by 2010 unless new
used to plan, collect (acquire), access, exchange and archive data required for technologies and strategies can turn things around,” observes Kevin
conduct, management, analysis, and reporting of the trial”. Electronic data Davies, PhD, Editor in Chief of Bio-IT World.
capture (EDC) is one element of this, and the adoption of this technology to
drive forward drug research is gaining pace, championed by the However, for every one advance there are at least two new questions that
pharmaceutical industry, primary healthcare providers and regulators. The need to be answered. EDC means that pharma are now swimming in
next step, or ‘eClinical Phase II’, is to move from a data-capture-centric world deep pools of information; the next big challenge is to efficiently store
to one of data exploitation and exploration. All stakeholders have a vision of and make sense of it all.
technology convergence that will provide efficiencies in drug development,
greater patient safety and improvements in patient care. Although still in its Industry Acceptance
early stages, eClinical has the power to transform pharmaceutical research Last year, Cambridge Healthtech Institute (CHI) conducted a survey on the
and development, and the continuing evolution of technology will help to practices, views and plans of 55 pharma directors and vice presidents –
advance convergence across the value chain. many of whom were from top 20 firms – concerning a variety of
technologies that have an impact on clinical trials now and in the future.
Technological development continues apace, fuelled by Moore’s law – According to the CHI data, half of respondents believed that EDC,
making more power available more cheaply and in a smaller package. particularly electronic case report forms (eCRFs), is in routine use today
Many different areas of modern living are in some way affected or (see Figure 1). A further 28% thought EDC would be endemic by 2008.
enhanced by electronic help, and the life sciences are no exception. “As Survey respondents indicated that advances such as the use of clinical
the biopharma industry grapples to cope with a variety of major biomarkers and offshoring of clinical trials are in mainstream use today.
challenges confronting it – from expiring patents to adverse events to Adaptive design is still a year off, and microdosing (‘phase 0’) will not
stagnating pipelines – it must continually search for better and more become routine until 2010.
Figure 1: When Do You Expect the Following Clinical Technologies and Practices to be Routinely Integrated Into Clinical Trials Across
Most Applicable Therapeutic Areas at Your Company?
Percentage agree
60
50
40
30
20
Biomarkers
EDC (eCRF)
10
Adaptive design
Offshoring
0 Microdosing
Now 2008 2010 2012
Year
EDC = electronic data capture; eCRF = electronic case report form; Microdosing = ‘phase 0’.
Source: Insight Pharma Reports, March 2006. Contact: Mike Goodman, Editor-in-Chief, mgoodman@healthtech.com
© TOUCH BRIEFINGS 2007 5
Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26