Clinical Trials in Poland 2007 : Market Research Report

Clinical Trials in Poland 2007

Published by: PMR Ltd.

Published: Jan. 1, 2007

Report methodology
Executive summary
Clinical trials market in Poland: Size of clinical trials market in Poland in the period 2005-2007; Major market events and trends in 2005-2006
Results of survey of 110 companies conducting clinical research in Poland: Introduction; Evaluation of situation on Polish clinical research market; Opportunities for and obstacles to expansion of clinical research market in Poland; Profile and market situation of largest companies conducting clinical research in Poland in 2005 and 2006; Origins of companies conducting clinical research in Poland; Workforce size in CRO and clinical research divisions; Financial situation; Number of clinical trials conducted; Number of patients participating in trials; Main areas of interest of companies conducting clinical trials in Poland; Phases of clinical trials conducted in 2005; Categories of drugs tested in 2005; Foreign operations
Comparative analysis of clinical research environment in Poland and selected other CEE countries: Hungary; Market size; Registration of trials; Ethics committees; Taxation of trials; Transport of materials; Development prospects; Russia; Market size; Patient recruitment; Legislation; Registration of trials; Ethics committees; Healthcare system; Insurance; Transport of materials; Recruitment of researchers; Development prospects; Czech Republic; Market size; Legislation; Registration of trials; Ethics committees; Healthcare system; Taxation of trials; Insurance; Development prospects; Ukraine; Patient recruitment; Legislation; Registration of trials; Healthcare system; Ethics committees; Cost of conducting trials; Transport of materials; Development prospects; Bulgaria; Market size; Patient recruitment; Legislation; Registration of trials; Ethics committees; Healthcare system; Insurance; Development prospects; Time required to register clinical trials in Poland and other European countries; Functioning of ethics committees in Poland and other European countries; Patient recruitment in Central and Eastern Europe; Investments by foreign companies in Poland compared to those in overall CEE region
Legal aspects of clinical research: Major legislation regulating clinical research in Poland; Conditions for conducting clinical trials in Poland; Issuing permits to conduct clinical research in Poland; Applying to commence clinical research; Fees for submitting applications for registration of a clinical trial; Deadline for processing applications; Principle of “tacit consent”; Refusal to issue a permit; Principles of Good Clinical Practice; Procedures relating to the work of ethics committees; Simplification of rules for conducting non-commercial trials in amendment to Pharmaceutical Law; Occurrence of adverse events during clinical trials; Inspections on clinical trials; Imports of medicinal products for use in clinical trials; Insuring clinical trials; Tax on clinical trials; Contracts in clinical trials; Changes regarding contract documents to be submitted to CEBK; Preliminary contracts; Tripartite contracts; Remuneration for researchers
Attitudes of Polish patients to clinical trials in comparison with attitudes in other countries: Participation in clinical trials; Factors influencing patient decision to participate in a trial; Risks and benefits of participating in clinical trials in patients’ eyes; Sources of information on clinical trials

Abstract

The report discusses the clinical trials market in Poland within the context of several other Central and Eastern European countries. It provides information on the types and quantity of trials conducted in Poland, the current market value and key developments with a bearing on the situation in the industry. It also overviews current trends as well as factors impeding and stimulating the development of this market.

In addition, the research PMR conducted provides an understanding of how pharmaceuticals companies and CROs view the Polish clinical research market. The report includes information on the business profiles of the participating enterprises, their current financial standing, and their forecast future performance.

The report also compares the conditions for clinical research in Poland to the industry climate in other Central and Eastern European countries. Selected countries were compared in terms of the key factors determining the efficiency of the clinical research process, namely: patient recruitment, legislation, trial registration, ethical approval, material transport, market size, taxation and research costs. The comparative analysis relied primarily on indepth interviews with members of the management of firms engaged in clinical research in the discussed countries.

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Clinical Trials in Poland 2007

Table of Contents

Abstract