Controlling the Increased Complexity of Electronic Clinical data Collection and Management Technology by data Modeling a
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Drug hiformorion Journal. Vol. 36, pp. 683-692, 2002 Printed in the USA. All rights reserved.
Copyright Q 2002 Drug Information Association Inc.
CONTROLLING THE INCREASED COMPLEXITY OF ELECTRONIC CLINICAL DATA COLLECTION AND MANAGEMENT TECHNOLOGY BY DATA MODELING AND SYSTEM ENGINEERING ULOPALM,MD, MBA Director Clinical Data Management Strategies, Schering-Plough Research Institute, Kenilworth, New Jersey
Economic realities are forcing pharmaceutical research and development to become more productive. A lot of hope is put on new information technologies, including electronic data capture. Howevec adding new technologies to existing legacy systems bears the risk of creating informational chaos. This can be avoided by system engineering and data modeling, whichfocus on the technology independent essence of a system. Computeraided system engineering tools translate logical models into real databases. As the aeronautical industry proves, rigorous computer-assisted system engineering and modeling is the way to manage high1.v complex systems successfully. The pharmaceutical industry has yet to make serious contributions to the planning and designing of complex systems. Key Words: Electronic data capture; Clinical research; Data modeling; Entity-relationship model (ERM); Computer-aided system engineering (CASE)
INTRODUCTION FOR MORE THAN 30 years, the pharmaceutical industry was one of the most flourishing industries in the world. According to Fortune magazine, between 1960 and 1990 the profits of the United States pharmaceutical companies were frequently 50% higher than the median profits of the 500 largest United States companies (1). Since then, however, many large pharmaceutical companies have increasingly faced an uphill battle to maintain their profit margins, as evidenced by the recent wave of mergers. Because their most lucrative patents
Reprint address: 010 Palm, MD, MBA. ScheringPlough Research Institute, 2015 Galloping Hill Road, Kenilworth, NJ 07033-1300.
are expiring, research-oriented pharmaceutical firms have continually lost market share to producers of generic drugs, producers that are not burdened by research and development (R&D) costs. The situation in pharmaceutical research will become even more critical in the coming years. In the United States, the patents will shortly expire on more than half of the 50 most important medicines which have a combined market value of almost $10 billion. While research-oriented firms must cope with more slowly expanding profits or even with losses, the R&D costs for new drugs have increased disproportionately, from about $54 million in the 1970s to more than $300 million in the mid 1990s and to about $500 million by the year 2000 (2,3,4). In addition, the development of new prescription drugs currently takes up to about
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12 years. In 1965, the development cycle lasted an average of about three years (5). The enormous increases in development cos
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