Incorporating Affiliates and Contract Research Organizations into Global Clinical Trials
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Copyright 0 1999 Drug Information Association Inc.
INCORPORATING AFFILIATES AND CONTRACT RESEARCH ORGANIZATIONS INTO GLOBAL CLINICAL TRIALS S. MICHAELHARRILL Lilly Research Laboratories, Indianapolis. Indiana
JANEM. BOSWCK Covance, Princeton, New Jersey
TAYLOR J. CROUCH PAREXEL International, Boston, Massachusetts
GERALDINE CAHILLANE Covance, Dublin, Ireland
HUGHWATSON Searle European R&D, Paris, France
SUSANM. MELOY Lilly Research Laboratories, Hamburg, Germany
Globalization of clinical trials, and the complexity surrounding the execution of these trials, has stimulatedpharmaceutical companies to review their decision making processes to include inputfrom affiliates and outsourced vendors that will be involved in the conduct andexecution of the trial. In determining how the study will be directed and which affiliates and contract research organizations (CROs) will be used, registration requirements must be balanced with commercialization needs. Communication is much more complex and affects all aspects of execution from investigator selection to project management. Centralized (eg. corporate) or decentralized (eg, regional) decision making models have an impact on timelines and achievement of milestones. This report identifies the challenges in conducting global clinical trials and addresses issues such as affiliate and CRO selection, project management, investigator selection, site management, on-site monitoring, and regulatory issues. Audience input was solicited and compiled through interactive electronic device technology. An analysis of the results is provided in this papes Key Words: Multinational trials; Affiliates; CROs; Project management; Investigator site selection; Site management; SMOs; On-site monitoring; Regulatory; Decision making models
This paper is a summary of an interactive panellaudience discussion entitled “Incorporating Affiliates and Contract Research Organizations in Global Clinical Trials” held at the DIA 34th Annual Meeting, June 10, 1998, in Boston, Massachusetts. Panelists consisted of representatives from major drug companies and international contract research organizations. Reprint address: S. Michael Harill, Lilly Research Laboratories, Indianapolis, IN 46285. E-mail:
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S. M . Harrill, J. M.Boswick, T. C. Crouch, G. Cahillane, H. Watson, and S. M . Meloy
INTRODUCTION
S. Michael Harrill, Lilly Research Laboratories IN THE EARLY 1990s, pharmaceutical companies in the United States entered into an era of globalization of clinical trials, requiring them to take a close look at the possibility of decentralizing their decision making processes. Until recently, major decisions concerning international trials were generally made in the corporate offices. Affiliate pharmaceutical company offices (“affiliates”) were often excluded from the critical decision making responsibilities and involved only in the tactical fulfillment of conducting clinical trials in their
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