Biostatistics and Data Management in Global Drug Development
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BIOSTATISTICS AND DATA MANAGEMENT IN GLOBAL DRUG DEVELOPMENT REGINAESSER Biostatistician, Biostatistics and Data Management, Merck KGaA Darmstadt, Germany
Today, pharmaceutical companies want to enter all major markets of the world with their drugs as early as possible and, therefore, perform global development programs that consist of clinical studies conducted in a multinational setting almost all over the world. Usually, several subsidiaries contribute to such a program. International teams are established and assume responsibility for particular tasks within the clinical project. Biostatistics and data management would be handled by a project biometrical team consisting of project and study biostatisticians and data managers. Planning of biostatistics and data management for individual studies and project summaries, generation of standards, smooth and eflcient conduct of related activities, and corresponding documentation are their business. As all this becomes increasingly complex and because time must be reduced to a minimum, standardization and worvlow management are of great importance. This article will outline the respective steps involved and propose a model of how biostatistics and data management can be approached in global drug development. Key Words: Clinical development; Biostatistics; Data management; Biometrical team; Standardization
INTRODUCTION
departments and associated biostatistics and data management units. Others may work TODAY, PHARMACEUTICAL companies with contract research organizations (CROs) want to enter all major markets of the world that have a worldwide network of subsidiwith their drugs as early as possible. The aries. most efficient way to achieve this is to perThe various subsidiaries of the company form a global developmentprogram that conitself or of a CRO will assume responsibility sists of clinical studies conducted in a multifor the conduct of clinical studies in their national setting almost all over the world. area. However, these studies are planned to Such a program minimizes replication of decontribute to a global development project velopment steps in individual countries and and, therefore, have to be planned by a cenby this means, concentrates resources (1). tral team according to a global clinical develUsually, several subsidiaries of an internaopment plan, taking global project standards tional pharmaceutical company located in into account. Compliance with project stanseveral countries contribute to a global drug dards defined for data management and biodevelopmentprogram and often at least some statistics is extremely important in a global of them have their own clinical development clinical development setting. Otherwise, the preparation of across study summaries and Reprint address: Regina Esser, Biostatistics and Data dossiers will turn out to be very complicated, Management, Merck KGaA Darmstadt, Frankfurter Str. time consuming, and unsatisfactor
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