EDC in use 
Figure 1.
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Altogether, 123 CRAs from nine companies in Germany responded to the survey (see Figure 1). The total response rate was approximately
50%. All of the participating pharmaceutical companies were known to routinely use EDC for their trials.
As most of the CRAs in Germany are young academics, the majority of survey participants were between 25 to 40 years old; one
third (33.3%) were between 26 and 35 years; and another slightly smaller group (27.6%) 35 to 40 years old. Regarding their
general job experience, more than one third of the survey participants (35.8%) have worked as a CRA for one to three years,
22% for two to four years, and more than 30% for at least seven years. Concerning the specific experience of the survey participants
with EDC trials, half of the group (52.8%) had good experience, meaning they were involved in one to three EDC trials, while
the second half had considerable expert knowledge, having been involved in more than four EDC trials. 
Figure 2.
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Sites involved included hospitals (52%), general practitioners (33.3%), and specialists (10.6%). A small percentage were site
management organizations (1.6%) or other types of sites not specified (2.4%). Looking at their EDC experience, more than 50%
of them were "familiar" with this technology. As shown in Figure 2, the systems used were primarily market leaders.
Main results 
Figure 3.
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The majority of the participants perceived EDC as a valuable tool for their activities on site. They were satisfied with all
practical aspects of the technology, such as navigation within the system (e.g., the possibility for cross checks and consistency
checks to enable source data verification). Moreover, they preferred the paperless approach for their daily monitoring activities
regardless of the system in use (see Figures 3 and 4).
Figure 4.
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The vast majority of the CRAs clearly favored the EDC system over traditional pCRF with regard to query resolutions. A majority
of the participants (75.6%) stated that query handling was easier with an EDC tool compared to pCRFs. However, the most important
advantage of EDC for 87% of the participants was less problems with bad handwriting—a parameter that might have been underestimated—followed
by better site status information (63%) and better patient data overview (63%).
Technical issues such as time needed to solve technical problems (81%), inexperienced site staff (66%), and the need for training
(53%) were seen as the main disadvantages. Nevertheless, almost 80% of the CRAs rated their overall satisfaction as "good"
or "very good." In their answers to the survey's summary questions, they did say that some improvements could be made regarding
the speed of data transmission. However, in today's age of growing information highways and increasing broadband speed, this
will probably not be a lasting issue. CRAs prefer EDC Looking at the overall results of the survey, one can conclude that sponsors, sites, CRAs, and the EDC systems themselves
seem to be ready for the eClinical journey—at least with respect to the practical implications of EDC on site. The results
show that the vast majority of the CRAs were satisfied with all practical aspects of the technology. Moreover, they preferred
the paperless approach for their daily monitoring activities, and there were no significant practical obstacles beside improving
the speed of data transmission. Altogether, EDC systems these days appear to be mature enough to facilitate and support the
monitoring on site—one of the most time-consuming and expensive tasks within clinical development.5 The main EDC disadvantages mentioned in the survey, such as the time needed to resolve technical problems, are perhaps the
price that has to be paid in order to benefit from the new technology. However, this does not explain why EDC is not used
more frequently in clinical trials. There must be other reasons. One possible reason could be that using EDC is not just about
using a new technology instead of a pencil; it has a deep impact on clinical research and on how it is conducted in general.
It needs a full set of change management activities. However, there is no proof that this is, in fact, the reason why paperless
clinical trials are still not more common. This has to be investigated further.
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