Transcend Global and Corporate Boundaries During Drug Development

Authors: Foit DJ, Walawander CA, Grasela TH, Hitchcock D
Conference: DIA
Keywords: data assembly, data management, decision-making, drug development process, hypertext data analysis, internet communication, knowledge portal, OODA, PERSPECTIVE, web-based
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Abstract

Objectives: We developed an innovative and alternative web-based strategy which combines a hypertext environment with human intelligence and creativity to lead a scientific audience through complex statistical analyses with the goal to enhance decision-making.

Methods: A geographically-dispersed pharmaceutical company and Cognigen were involved with the program. A secure internet portal was used as the entrance for communication and collaboration among the scientists, data managers, and administrators involved. PERSPECTIVE Hypertext Data Analysis Mapping software was used as the differentiating component of this web-based strategy. The lead scientist used the software to document and organize the analysis results for the project. A variety of tools were used to provide passive interactive communication between scientists at their own discretionary time. Lastly, virtual meetings were conducted over the web using a web tour mechanism.

Results: The results of the complex analysis were documented and presented in PERSPECTIVE over the portal and were traversed by the scientists at their own discretion or as part of a guided discussion group. The collaboration of the scientists among the cross functional departments allowed interactions about the analysis to proceed across the traditional barriers within the pharmaceutical industry, provided education to clinicians and scientists not familiar with the analysis techniques, and improved collaborative knowledge creation. As a result, since approval of the analysis was proceeding along with performance, the final conclusions of the program were approved simultaneously. This potentially saved two months to a year of review time over traditional methods of review and approval of final program deliverables.

Conclusion: More information does not necessarily equate to better insight into a thought process. The cognitive engineering approach used by this alternative web-based strategy is possible, successful, and a cost-effective solution that has the potential to optimize product approvability and marketability.

Drug Information Association (DIA); Denver, Colorado; July 2001

By Darcy J. Foit, Cynthia A. Walawander, Thaddeus H. Grasela