Clinical Trials in Central/Eastern Europe: Industry Viewpoint
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Drug Information Journal. Vol. 32. pp. 129-133. 1998
Copyright 0 1998 Drug Information Association Inc.
Printed in the USA. All rights reserved.
CLINICAL TRIALS IN CENTRALEASTERN EUROPE: INDUSTRY VIEWPOINT BENONALILLIANNATORFF, MD, MFPM Pharm-Olam International (UK) Ltd, Berkshire, England
Over the past 15 years pharmaceutical companies and contract research organizations (CROs) have increased their presence in Central and Eastern Europe, and taken increasing advantage of the opportunities f o r conducting clinical trials there. Data from studies in these countries have been submitted by several Western European and American companies for marketing approval over the pastfive years and accepted by Western regulatory agencies and the Food and Drug Administration. Access to rare populations and a high prevalence of certain disorders puts countries of Central and Eastern Europe high on the priority list for clinical trials in some therapeutic areas. Additional numbers of patients are an asset where large populations are needed in multicenter Phase III studies. As enrollment is fast and compliance high, considerable time savings are achieved. There are. howevel; differences between running clinical trials in Western and CentraUEastern Europe and these will be considered. Key Words: Clinical trials; CentralEastern Europe
INTRODUCTION
lowing the political and economic revolution in the region. At the same time, contract reINTERNATIONAL PHARMACEUTICAL search organizations increased their activity, companies have increased their presence in and some of them opened local offices. The Centramastern Europe since 1980. Initially, number of clinical trials (mainly in Phases local marketing departments were set up I1 and 111) registered in Poland and Hungary which also conducted clinical trials that were in 1995 was over 150 and over 100 in the needed for local marketing authorizations. Czech Republic. For 1997, nearly 200 trials The medical departments of most large and were registered in Poland by September. middle sized companies were established in Why has the pharmaceutical industry the 1990s, mainly in Poland, Hungary, and moved so swiftly into the CentralEastern the Czech Republic, but some companies European countries? The answer is complex. ventured as far as Russia and Bulgaria, fol- In order to develop and register new medicines there is a dual need for sufficient data from clinical trials in as short a period of Presented at the DIA 33d Annual Meeting ‘‘Optimizing time as possible. One must be certain, howPharmaceutical Development: The Global Experience,” ever, that high quality data are obtained so June 22-26, 1997, Montreal, Quebec, Canada. that they will be acceptable to regulatory auReprint address: Dr.Benona Lillian Natorff, Pharmthorities worldwide. Provided both needs are Olam International (UK)Ltd, The Brackens, London Road, Ascot, Berkshire SL5 8BE, England, United fulfilled, the location of Phase I1 and I11 clinical trials is not crucial unless future marKingdom. 129 Downloaded from dij.sagepub.com by
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