(Photography: Jim Shive)
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Today, many businesses routinely capture data electronically for regulatory and business purposes. However, health care providers,
regulatory authorities, and the pharmaceutical industry have resisted this industry transforming technology for a long time
for various reasons.1 But the availability of electronic health data becomes more and more crucial for the quality of medical care.2 With respect to research activities, the same trend is seen as companies face increasing pressure to bring new, innovative,
and safe drugs to the market faster and in a more cost conscious way. Moreover, increasing concerns over product safety has
resulted in the need for more and longer trials and the need to use new electronic systems to make safety information available
more quickly.3
In addition, higher and increasing demands regarding data quality and availability are being requested by the regulatory authorities.
Electronic safety reporting, electronic clinical trial applications, and electronic submission via the Electronic Common Technical
Document (eCTD) are recent examples. Thus, there are several attempts to utilize new technologies toward the vision of eClinical—an
integrated electronic infrastructure that links all aspects of R&D, from planning to submission.
But what are the reasons that the majority of clinical trials still do not use EDC as a standard tool?4 Why do the majority of trials still use the traditional paper CRF (pCRF) to collect study data? One of the reasons could
be that the systems in use are not yet user friendly and customized enough to allow easy use on site. This would include data
entry and monitoring functions. Therefore, the main objective of the survey described in this article was to have a look for
practical implications of EDC on site. In search of practicality
For this purpose, a survey of 123 CRAs was conducted from November to December 2006 in Germany. CRAs were selected to report
about their experience with EDC on site because they have to deal with the practical implications of this technology. The
use of EDC has a major impact on CRAs' daily work with respect to their duties according to ICH-GCP (e.g., source data verification,
safety reporting, auditing, and query handling).
Moreover, CRAs are one of the key drivers for a successful EDC change management process, which can be influenced by their
satisfaction rate. Their practical experiences could give valuable information about the main advantages and disadvantages
of EDC and how it is perceived in comparison with the traditional paper approach. Therefore, the result of this survey might
help us understand why promising new technologies like EDC are still not commonly used in clinical research.
In order to qualify for participation in the survey, the CRA needed to be currently involved in at least one national or international
EDC trial conducted in Germany and in charge of at least one clinical trial conducted at a German site using pCRF. The questionnaire
mainly focused on the CRA's satisfaction with EDC, potential pitfalls in practice, and possible advantages and disadvantages
compared to pCRF. As it can be assumed that most of the CRAs were involved in more than one clinical trial at the time of
the survey, they were asked to focus on that trial.
