Pharmaceutical Executive Europe - March 2007 - (Page 22)

EDC: Are We Missing the Boat? Changing the way we think about electronic data capture is the key to harnessing its true commercial and operational potential, writes David A. Dworaczyk. he basic ideas and technology behind electronic data capture EDC have been around for decades. The effective use of EDC, however, has only come into its own in the last five years or so. As with any technology, evolutionary — and at times revolutionary — advancements have occurred in the last two to three years. Based on these rapid changes and advancements, it is not unreasonable to think that EDC experience that is more than three years old is probably no longer valid. However, even with all the interest, professional meetings, seminars and the creation/extinction of several EDC vendors, EDC has yet to achieve the level of acceptance and use that was once envisioned. It can be argued that the overall thinking of both vendors and users is too limiting and restrictive. A basic pretense is to ask the question, what would happen if we changed the way that we think about EDC? What could we envision if we stopped thinking of EDC as an end in itself — that is, a data collection modality — but rather as a robust and current data and information source? Could we create a common data source/hub/warehouse, with its origins at the patient data-field level, with direct links to other operational systems for greater gain? Based on gains and advances in technology and operating systems, this is not only possible but feasible today. T New perspectives at study level The common uses of EDC at the study level are well known and well addressed by the high-calibre technologies readily available. These uses commonly focus on collecting, monitoring, tracking, presenting and cleaning data from study sites for better data quality and faster study closure. Most uses, however, are mainly restricted to the study level, and seldom applied to a programme level, or have tight and direct integrated data links from supportive data sources. Direct linkages/feeds of data from other sources, such as clinical labs, interactive voice response IVR , electrocardiogram ECG core labs and/or e-diaries remain difficult tasks requiring multiple efforts for data reconciliation. If we did change the view that EDC was more than a data collection end in itself and was, rather, a true data source that could directly feed other systems, the opportunities for fundamental changes in internal operations could be tremendous. For example, if there was a true integration of a clinical study management system within an EDC platform, or an EDC tool within a study management system, all study/regulatory document-tracking updates could be done almost automatically. Electronic repositories for all studyrelated documents could be readily available to sites, sponsors and CROs with direct links to patient data and MARCH 2007 CLINICAL TRIALS MANAGEMENT 22

Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - March 2007

Linking People, Process and Technology
Building Alliances
Finding Success in Asia
Selecting South Africa
Advance from Europe
EDC: Are We Missing the Boat?
The Right Equipment
Next Stop: Vienna

Pharmaceutical Executive Europe - March 2007