Articles

Beyond the Value of EDC-
The eClinical Paradigm Shift

By Timothy Pratt, PhD
Originally published in The Monitor, December 2007

You can almost hear the readers' groans as you begin to write a paper like this. Not another piece lauding the benefits of electronic data capture (EDC)! If you have read this far, rest assured that this paper is not about the wonders of EDC. Ever since PhaseForward really opened up the EDC floodgates in 1997,1 a deluge of companies has come and gone, saturating the market with messages about efficiency, speed, and reduced cost to the point where EDC's advantages have become a given.2 In fact, some companies are now beginning to regard EDC as a commodity offering, and are thus subjecting vendors to reverse auctions.3 EDC adoption was its own paradigm shift in thinking and has gained so much momentum in the marketplace4 that its U.S. adoption rates are projected to have increased from 24.2% during 2005 to 45.2% at the end of 2007.5 (See Figure 1.)

This paper is about a new, somewhat quieter, but no less revolutionary paradigm shift that is under way-beyond EDC and towards eClinical, with the inclusion of clinical and operational metadata.6

Differentiating between EDC and eClinical is sometimes difficult, as the industry on occasion uses the terms interchangeably. Here are the definitions from the Applied Clinical Trials glossary 5.0 (2006):

  • EDC-The process of collecting clinical trial data into a permanent electronic form. (Note: "Permanent" in the context of these definitions implies that any changes made to the electronic data are recorded via an audit trail.)
  • eClinical-Clinical trial in which primarily electronic processes are used to plan, collect (acquire), access, exchange, and archive data required for the conduct, management, analysis, and reporting of the trial.7
  edc systems graphic  

In the context of this piece "eClinical" will be used to refer to a system that enables a clinical trial under one technology umbrella. When well executed, eClinical represents a paradigm shift beyond EDC.

Thomas Kuhn, who coined the phrase "paradigm shift" in The Structure of Scientific Revolutions,8 intended it to describe a radical, revolutionary way of thinking that turns existing thought processes on their heads and produces a whole new way of thinking and acting.9 However well worn, this term is appropriate for eClinical, and here's why.