Breaking new grounds: Deployment of electronic data capture (EDC) for clinical trials in China
Date | 01 May 2018 |
DOI | http://doi.org/10.1002/jsc.2199 |
Published date | 01 May 2018 |
RESEARCH ARTICLE
DOI: 10.1002/jsc.2199
Strategic Change. 2018;27(3):257–265. wileyonlinelibrary.com/journal/jsc © 2018 John Wiley & Sons, Ltd. 257
Abstract
Managerial understanding of the organizing logics and deployment of electronic data capture
(EDC) in clinical trials is fundamental to the capture of value from the system. We examine the
deployment of EDC in clinical trials in China. We argue that managerial understanding of the
organizing logics of EDC system is fundamental to the deployment and subsequent capture of
value from the system. We idened what we call the rhetoric of legimaon EDC, and the ac‐
ve separaon of knowledge forms of the old system as salient discursive pracces that has the
potenal to enable (or impede) value capture from EDC deployment.
1
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INTRODUCTION
China is expected to become the second largest healthcare market
by 2020 (IMS Consulng Analysis, 2011). Outside the United States,
China has also become a highly aracve global trial locaon because
it has a large paent pool and evolving regulatory condions (Kearney,
2006). The costs for performing Phase II and III trials in China can
range from 10% to 30% of the costs for running same trial programs
in the United States. There is sll a need to speed up the progress of
clinical trials to shorten research cycle and reduce the rate of data
errors. This has led to the emergence of electronic data capture (EDC)
and other e‐clinical technologies in conducng clinical trials in China.
EDC as a tool for data collecon and management in clinical trials is
not new. Developed on the basis of remote data entry (RDE) in the
early 1990s (Kiuchi & Kaihara, 1997; Mcfadden, LoPres, Bailey, &
Clarke, 1995), its capabilies lies in its ability to speed up the prog‐
ress of clinical trials to shorten the research cycle and reduce the data
error rate. As argued by Wen, He, and Liu (2010), most market analysts
believe that EDC will be the only way of future clinical trials and the
adopon and deployment of the technology is set to rise in the com‐
ing years (Health Industry Insights, 2007). Nevertheless, the adopon
and deployment of EDC in China has been very slow and lile insight
has been generated into how Chinese rms could eecvely deploy
the technology to improve their compeveness. The China Food and
Drug Administraon (CFDA) are working on local guidelines for EDC
use with reference to the U.S. Food and Drug Administraon’s (FDA)
21 CFR Part 11 regulaons (Health Industry Insights, 2007). In the
meanme, the CFDA recently began to accept e‐database from EDC
as part of the drug registraon trial submission le for market authori‐
zaon approval (Chung, Kukaa, & Jonhnson, 2006; Wen et al., 2010).
While more than 50% of clinical trials in the United States employ
EDC, a paltry 5% of clinical trials in China make use EDC (Luz, 2010).
Nevertheless, we know very lile about EDC implementaon in China,
and the extent to which Chinese rms are capturing value from the
system.
In this study, we examine how one Clinical trial company (Athena)
deployed an EDC system to expand their clinical trials and manage‐
ment service oerings. The company collaborates with OPENCLIN‐
ICA, LLC in Boston, USA, OpenClinica Enterprise Edion as Soware
as a Service (SaaS) EDC plaorm for its potenal clients. The object
of our study, therefore, is to examine how the company’s deploy‐
ment of EDC technology which has resulted in some salient qualita‐
ve improvements in the way work is organized. Contribung to the
extant literature on the strategic deployment of informaon technol‐
ogy within organizaons, our study extends our understanding of EDC
as a strategic informaon technology system that has been widely
credited with the ability to facilitate eecve management of clinical
trials in China, and the potenal for rms to capture value from suc‐
cessful implementaon of EDC in clinical trials.
The arcle is structured as follows. First, we provide an overview
of clinical trials in the pharmaceucal industry and the emergence
of EDC in clinical trial management. Next, we review some of the
Breaking new grounds: Deployment of electronic data capture
(EDC) for clinical trials in China*
David Sarpong1 | Ivan Tjong‐A‐Hung2 | David Botchie3
1Bristol Business School, Bristol, United
Kingdom
2Athena Healthcare Consultancy, Shanghai,
China
3Open University, Milton Keynes, United
Kingdom
Correspondence
David Sarpong, College of Business, Arts
& Social Sciences, Brunel Business School,
Brunel University London, Kingston Lane,
Uxbridge UB8 3PH, United Kingdom.
Email: David2.Sarpong@uwe.ac.uk
* JEL Classicaon Codes: M00, O33.
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