Articles
Beyond the Value of EDC-
The eClinical Paradigm Shift
By Timothy Pratt, PhD
Originally published in The Monitor, December 2007
Where We Have Been
It's often of value to reflect on the past to understand the present, especially with technology. Historically, EDC was preceded by remote data entry (RDE)- basically a locally distributed set of software, often on a dedicated special computer, that people would use to enter data locally, and then "sync up" with the sponsor database via modem (or in the really early days, by sending the whole computer back to the sponsor). Although some degree of dynamic edit checks were incorporated to make the data a little cleaner than paper, there were limitations and major problems of "immediacy"; after all, the dataset was complete only when everyone synced up on schedule (which rarely happened) or if someone didn't spill coffee on the computer or steal it (which often happened).
Then came EDC at about the same time as the Internet really took off in the late 1990s. Early versions of EDC were simply web-enabled RDE systems and carried with them some of that early technology baggage; they would work only on particular operating systems or required certain software (usually those operating systems were MS-DOS, which morphed into Windows), and often the browser required was Internet Explorer, so users of FireFox, Netscape, Linux, or a Mac were precluded from using these systems.
Eventually, some of the major EDC players began to gain traction in the marketplace. They were great solutions for their time, and much effort was put into market development: better, cleaner, faster, cheaper-the classic EDC mantra. These early systems were paradigm shifts compared to paper methodologies, but the dark side of the technology has only just begun to emerge as the eClinical revolution gains traction.
