As so many articles have noted,1 the uptake of electronic data capture (EDC) and associated technologies has continued to
be disappointing. Even though 20 years ago experts predicted that electronic case report forms (CRFs) would replace paper
as a natural consequence of the introduction of computers, this has not been the case.
Recent analyst research2 has identified that at best only 30% of ongoing clinical trials are conducted using EDC. Justification
for this slow acceptance has come from many varied sources. Before we consider this, however, let's examine what a pharmaceutical
company looks for when selecting a software solution vendor.
Financial and organizational stability. A pharmaceutical company will not commit to a vendor unless it has a solid balance
sheet, funds to resource its current trial support, and proven long-term sustainability as a business.
Global presence and scalability. Although there are some requirements for local providers, the stage for the majority of clinical
trials is global; a vendor company needs the infrastructure to support this.
Experience in the marketplace. This is a challenging focus area, where failure is not an option. For this reason, vendors
that are viewed as "e-veterans" are often favored.
Robust, reliable technology. This should be encapsulated by excellent support processes.
A cursory glance at the eClinical vendor market will show as many as 150 companies. Although many cannot offer the full package,
an emerging subset of vendors do possess these desired characteristics. So perhaps this slow adoption rate of e-technologies
cannot be fully attributed to the so-called "unstable vendor market."2
In addition to the desired vendor characteristics, the pharmaceutical company needs to consider the demands of the clinical
program.
- Will the external stakeholders accept the technology? Do they actually want it?
- Is the infrastructure stable enough to conduct EDC trials in all of the countries which have the desired patient populations
(often Central European or African/Asian countries)?
- How is source data verification managed in this environment?
- How will EDC affect the internal organization?
- What is the opinion of the regulatory authorities of data collected in this way?
- Is there a danger of data being rejected as noncompliant?
- When will we see a return on investment? How can this be measured when so many of the EDC benefits are qualitative rather
than quantitative?
In their efforts to address these challenges, the approach of some pharmaceutical companies has been laudable. Their piloting
trials have taught them the issues are more about people and process than about technology.3 Figure 1 illustrates the challenges
confronting pharmaceutical companies that employ EDC. Instead of extended use of the technology, various issues have led to
consecutive piloting.
Figure 1. Expected electronic data capture industry growth has turned into consecutive piloting.
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Current "EDC double data entry" paradigm Pharmaceutical companies have recognized that going eClinical changes the trial process from a series of sequential tasks
to a parallel process where a continual review of data will bring about the best results. Impact analyses were conducted to
examine the change that EDC would bring, and these resulted in some restructuring efforts within the organizations. There
have been investments in developing the functionality of the EDC system so that it is not only an application to capture clinical
data, but also for review and analysis. But even with all of this work, the growth in acceptance of EDC has not been exponential
as predicted. How can this be explained?
If we look at the most critical aspect of the clinical trial-the investigator and the site team-we can see that EDC has not
been the correct solution. Although we have made improvements to system functionality, invested in high-speed connections
to the Internet, and even provided extra resources for data entry, the bottom line is that EDC is an additional burden to
the site. For the majority of clinical trials, due to the uncertainty surrounding the regulations, we have doubled the work
for the sites.
In the paper environment, the paper CRF was received in-house and entered by one data entry clerk and verified by another.
This double data entry process was supposed to be removed by the introduction of EDC. The reality is that for the sponsor
organization it has disappeared, because the sites now perform this redundancy.
This "EDC double data entry" is caused by the assumption that a paper source is needed for online EDC systems. That means,
essentially, that the investigator records the patient data in the source notes or a pro forma of some kind, and then enters
it into the EDC system some time later. In a recent survey conducted by the industry group EDM Forum,4 840 investigators (both
experienced and nae in EDC) were asked what the biggest barrier was to wide-scale use of EDC: this double data entry process
was number one. Until global health care evolves to the point where all patient data is stored electronically and we are in
a position to copy selected views of this information in a validated exchange, we need a solution to reduce the site burden
of EDC and clinical trial conduct in general.
It is evident that the process reengineering and impact analysis conducted by the pharmaceutical organizations do not go far
enough. The clinical trial process was conceived, designed, and refined using paper as the medium for collecting clinical
data. All the procedures and functional roles that make up the clinical data process have been structured around paper. Although
there have been some efforts to recognize this internally, the external processes and the site expectations have not been
modified.
