Clinical Trials in Poland 2008-Development forecasts for 2008-2010

Clinical Trials in Poland 2008-Development forecasts for 2008-2010

Clinical trials in Poland 2008 is the second edition of our research of the sector and thus it offers you a unique opportunity to keep track of market trends and developments over the last several years. It provides a comprehensive study of the sector, with data on its value and development prospects.

Based on a recent PMR research and exclusive interviews with experts in the field, the report reveals the attitudes of managers of pharmaceutical companies and CROs towards the market, and situates Poland’s clinical trials in the context of other Central and Eastern European countries.

Clinical trials in Poland 2008 begins with a presentation of key facts regarding the market’s size and condition. It provides data on:

• key trends and circumstances affecting the sector in 2007 and 2008
  
  
• present-day market size with forecasts for 2008-2010.

Then we present the results of a recent PMR research, which was carried out on the management staff of over 60 CROs and pharmaceutical companies active on the Polish market. It has revealed the following information:

• the current and anticipated situation on the market
  
  
• market growth opportunities and obstacles
  
  
• the average registration time for clinical trials in Poland
  
  
• main characteristics and market standing of major companies conducting clinical trials in Poland in 2007 and 2008 (data presented in an aggregated form).
  
  
  
  
• The report also includes a comparative analysis of conditions governing the performance of clinical trials in Poland and in selected CEE countries.

Operations of major pharmaceutical corporations active in CEE countries are then presented, with special attention given to companies active in Poland. This includes the following details :

• number of trials
  
  
• location
  
  
• therapeutic areas.

We also provide profiles and basic information on the biggest Clinical Research Organisations (CROs) in Poland.

Finally, the report includes crucial information on legal conditions regulating the market. It provides the latest data on, among others, the following aspects:

modifications to be introduced by the anticipated Clinical Trials Act


• legislation governing the involvement of minors in clinical trials
  
  
• responsibility in clinical trials
  
  
• taxation
  
  
• inspections
  
  
• personal data protection
  
  
• researchers' remuneration.

 
 

Report methodology

Executive summary

Size of clinical trials market in Poland 2005-2010

Major events and trends on the clinical

research market

Major market events and trends 2007-2008

Forecast market events and trends 2008-2010

Size of Polish clinical trials market 2005-2010

Results of survey of 110 companies conducting clinical research in Poland

Introduction

Evaluation of situation on Polish

clinical research market

Assessment of current situation

Predictions for the coming 12 months

Development forecasts for Polish clinical trials market

Annualised growth in patient number

Annualised growth in market size

Trends anticipated for the Polish clinical trials market

Opportunities for and obstacles to expansion of clinical research market in Poland

Clinical trial registration in Poland

Assessment of CEBK

Average trial registration time

Profiles and market situation of firms conducting clinical research in Poland

Financial standing

Firms with foreign investors

Number of clinical trials conducted

Number of patients participating in trials

Main areas of interest of companies conducting clinical trials in Poland

Categories of drugs tested in 2007

Therapeutic groups with best research prospects

Length of experience of clinical research firms in Poland

Employment at CRO and pharma firms

Foreign operations

Comparative analysis of clinical research environment in Poland and selected other CEE countries

Comparison of basic parameters in selected CEE countries

Comparative analysis of clinical trials conducted by international concerns in Poland and in the CEE region

Pfizer

GlaxoSmithKline

Roche

Sanofi-Aventis

Bristol-Myers Squibb

AstraZeneca

Novartis

Eli Lilly

Merck&Co.

Johnson&Johnson

Amgen

Wyeth

Trial registration

Costs of conducting a study

Patient recruitment

Researcher qualifications

Trial quality

Clinical trials inspections in Central and

Eastern Europe

Number of clinical trials in CEE

Russia

Poland

Czech Republic

Hungary

Slovakia

Romania

Ukraine

Bulgaria

Profiles of select CROs active in Poland

Quintiles Poland

KCR

Scope International

MTZ Clinical Research

Parexel Polska

Monipol

Paragon Biomedical

MDS Pharma Services Poland

Averion International

PSI Pharma Support

Covance Polska

PPD

Legislative environment

Key legislation and institutions regulating

clinical research in Poland

Obtainment of clinical trials licence in Poland

Applying to commence clinical trials

Fees for submission of clinical trial registration

application

Duration of processing of applications

Principle of “tacit consent”

Refusal to issue a licence

Procedures relating to the work of

ethics committees

Adverse events during clinical trials

Insuring clinical trials

Claims in clinical trials

Contracts in clinical trials

Changes regarding contract documents to be submitted to the CEBK

Preliminary contracts

Tripartite contracts

Liability in clinical trials

Civil liability

Product liability

Liability in tort

Contractual liability

Criminal liability

Disciplinary responsibility

VAT on clinical trials

Personal data protection in clinical trials

Medical documentation

Remuneration of researchers

EudraCT database

Outsourcing of clinical trials

Clinical trials with minors

National standards

European standards

Planned amendments to clinical trial regulations

Clinical Trials Act

Ordinance on Template of Application to Commence a Clinical Trial

Application to the Health Ministry

Application to Bioethics Committee

Changes planned in the “minor amendment” to the Pharmaceutical Law

Non-commercial trials

Inspections of clinical trials

Investigational medicinal product

List of graphs

List of tables

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