REV: DECEMBER 20, 2006
ROBERT S. HUCKMAN
MARK J. COTTELEER
Procter & Gamble: Electronic Data Capture and
Clinical Trial Management
Ray D’Alonzo reviewed his notes. He realized that he had much more material to discuss than he could cover in the 45 minutes allotted for his presentation to the R&D Leadership Team. As the Associate Director for Clinical Data Management at Procter & Gamble (P&G), D’Alonzo had been asked to discuss strategies for reducing the length of time P&G took to complete clinical trials for its prescription drugs. The trials, which were required before receiving approval to market a drug in the United States, could take anywhere from several months to several years to complete. Like his colleagues, D’Alonzo had heard the oft-cited claim that, for the average prescription drug, each day of delay in market entry for the product costs the sponsor roughly $1 million in lost sales. While D’Alonzo thought that number might be a bit high, there could be no question that there was real value to P&G in reducing the time it took to get a drug through trials. In many respects, D’Alonzo was pleased by the efforts that he and his colleagues had made in improving trial performance at P&G. A culminating event in these improvement efforts was the recent completion—in May 2001—of six pilot trials using Web-enabled electronic data capture (EDC), a new technology for collecting trial data from investigator sites (i.e., physician offices and hospitals throughout the world) via the Internet. Historically, P&G, like most other pharmaceutical firms, had relied upon paper-based methods for collecting this information. While the pilot trials suggested that the Web-enabled EDC could significantly shorten the lead time for clinical trials, it was also clear to D’Alonzo that use of the technology would require substantial changes with respect to trial management both within P&G and between P&G and investigator sites. As D’Alonzo pondered whether to recommend Web-enabled EDC as the default standard for all future trials at P&G, he could not help but acknowledge the fact that the ultimate costs and benefits of this technology were still uncertain. Could the use of a technology like EDC really add value to the clinical trials process, or was it just another dot-com bust waiting to happen? If it existed, where would the business value come from? Finally, how would the process changes brought on by the use of EDC play out among the relationships within P&G, and between the company and the investigative sites upon which it relied for the success of its trials?
________________________________________________________________________________________________________________ Professor Robert S. Huckman and Professor Mark J. Cotteleer (Marquette University) prepared this case. HBS cases are developed solely as the basis for class discussion. Cases are not intended to serve as endorsements, sources of primary data, or illustrations of effective or ineffective management.
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Procter & Gamble: Electronic Data Capture and Clinical Trial Management
Overview of Drug Development and Approval in the United States As had been the case for many years, the drug development process in the United States in 2001 was lengthy and uncertain (Exhibit 1). The average “out-of-pocket” cost associated with developing a new drug was over $403 million. When capitalized to...