Clinical trials in Poland 2008

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 over 100 pharmaceutical companies and CROs towards the market, and situates Poland’s clinical trials in the context of other CEE countries.

A database of over 60 CROs active on the Polish market is also added to the report as a supplement.

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.

We then present the results of a recent PMR research, which was carried out on the management staff of over 100 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 Central and Eastern European countries.

Operations of major pharmaceutical corporations active in Central and Eastern European 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 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.

A database of over 60 CROs active on the Polish market is added to the report as a supplement, containing the following information:

- company name
- address
- website
- e-mail
- fax number
- telephone number

Target Readership

Clinical trials in Poland 2008 will be particularly useful to:

- Clinical Research Organisations (CROs) and pharmaceutical companies interested in launching operations in Poland or cooperating with their Polish counterparts
- pharmaceutical companies and CROs keen to keep track of Poland’s clinical trials market
- other companies active on the Polish clinical trials market, such as Site Management Organisations (SMOs) or companies interested in providing medical equipment and clinical trial materials
- decision makers who need to gain a thorough understanding of the key trends on the market.

Latest version of this report is available here: Clinical trials in Poland 2010

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1. Report methodology

2. Executive summary

3. 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

4. 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

5. 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

6. 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

7. 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
8. List of graphs
9. List of tables

List of graphs

1. Value of clinical research market in Poland (PLN m), best-case scenario, 2005-2010
2. Value of clinical research market in Poland (PLN m), worst-case scenario, 2005-2010
3. Value of clinical research market in Poland (PLN m), best-case scenario, 2005-2010
4. Value of clinical research market in Poland (PLN m), worst-case scenario, 2005-2010
5. Assessment of current situation on clinical research market in Poland, May 2008
6. Main reasons for positive assessments of clinical trials market in Poland, May 2008
7. Will the situation in the clinical research sector in Poland deteriorate, improve or remain unchanged in the next year?, May 2008
8. Will the number of patients participating in clinical trials increase, decrease or not change in 2008 relative to 2007?
9. In your opinion, by how much will the number of patients participating in Poland in clinical trails increase in 2008 relative to 2007 (% of respondents)?
10. Will the Polish clinical trials market grow, contract or not change in 2008 relative to 2007?
11. In your opinion, by how much will the Polish clinical trials market expand in 2008 relative to 2007?
12. There will be more academic clinical trials in Poland in the future, May 2008
13. Poland will be losing its competitive edge as a place to conduct clincial trials in CEE, May 2008
14. More Phase I trials will be organised in Poland, May 2008
15. Key barriers to business development of firms active on the clinical trials market in Poland, 2006 and 2008
16. Key factors which could stimulate development of clinical trials market in Poland, 2006 and 2008
17. How would you assess CEBK’s work in clinical trial registration in Poland, May 2008
18. Key reasons for negative assessments of the CEBK’s work in Poland, May 2008
19. Average time it takes to register a clinical trial in Poland (no. of firms), May 2008
20. Assessment of the current financial standing of your clinical research firm in Poland relative to a year earlier, May 2008
21. Assessment of financial standing of clincial research firms in Poland, 2006 and 2008
22. Respondents’ predictions on financial standing of their clinical research firms in Poland for the next 12 months, May 2008
23. Respondents’ predictions on financial standing of their clincial research firms for the upcoming year, 2006 and 2008
24. Polish and foreign firms on the clinical research market in Poland, 2008
25. How many trials did your company conduct in Poland in 2007?, May 2008
26. Number of patients involved in clinical trials for the average company in Poland, 2005-2008
27. Therapeutic groups subject to research in Poland (% of firms engaging in a given type of trial), May 2008
28. What therapeutic groups will be increasingly tested in clinical trials in Poland?, May 2008
29. Number of years your company has been present on the Polish clinical trials market, May 2008
30. Does your firm organise clinical trials outside of Poland?, May 2008
31. Countries, in which firms present in Poland most often organise trials (no. of firms), May 2008
32. Share of CEE countries in total number of trials in the region, May 2008
33. Number of clinical trials conducted in Poland by international pharma concerns, May 2008
34. Number of clinical trials conducted in CEE by Pfizer, May 2008
35. Share of trials conducted in Poland and in CEE in all trials conducted by Pfizer, May 2008
36. Share of trials conducted in Poland in trials conducted by Pfizer in CEE, May 2008
37. Therapeutic areas of Pfizer trials conducted in CEE, May 2008
38. Number of clinical trials conducted in CEE by GlaxoSmithKline, May 2008
39. Share of trials conducted in Poland and in CEE in all trials conducted by GSK, May 2008
40. Share of trials conducted in Poland in trials conducted by GSK in CEE, May 2008
41. Therapeutic areas of GSK trials conducted in CEE, May 2008
42. Number of clinical trials conducted in CEE by Roche, May 2008
43. Share of trials conducted in Poland in trials conducted by Roche in CEE, May 2008
44. Therapeutic areas of Roche trials conducted in CEE, May 2008
45. Number of clinical trials conducted in CEE by Sanofi-Aventis, May 2008
46. Share of trials conducted in Poland and in CEE in all trials conducted by Sanofi-Aventis, May 2008
47. Share of trials conducted in Poland in trials conducted by Sanofi-Aventis in CEE, May 2008
48. Therapeutic areas of Sanofi-Aventis trials conducted in CEE, May 2008
49. Number of clinical trials conducted in CEE by Bristol-Myers Squibb, May 2008
50. Share of trials conducted in Poland and in CEE in all trials conducted by Bristol-Myers Squibb, May 2008
51. Share of trials conducted in Poland in trials conducted by Bristol-Myers Squibb in CEE, May 2008
52. Therapeutic areas of Bristol-Myers Squibb trials conducted in CEE, May 2008
53. Number of clinical trials conducted in CEE by AstraZeneca, May 2008
54. Share of trials conducted in Poland and in CEE in all trials conducted by AstraZeneca, May 2008
55. Share of trials conducted in Poland in trials conducted by AstraZeneca in CEE, May 2008
56. Therapeutic areas of AstraZeneca trials conducted in CEE, May 2008
57. Number of clinical trials conducted in CEE by Novartis, May 2008
58. Share of trials conducted in Poland and in CEE in all trials conducted by Novartis, May 2008
59. Share of trials conducted in Poland in trials conducted by Novartis in CEE, May 2008
60. Therapeutic areas of Novartis trials conducted in CEE, May 2008
61. Number of clinical trials conducted in CEE by Eli Lilly, May 2008
62. Share of trials conducted in Poland and in CEE in all trials conducted by Eli Lilly, May 2008
63. Share of trials conducted in Poland in trials conducted in CEE by Eli Lilly, May 2008
64. Therapeutic areas of Eli Lilly trials conducted in CEE, May 2008
65. Number of clinical trials conducted in CEE by Merck&Co., May 2008
66. Share of trials conducted in Poland and in CEE in all trials conducted by Merck&Co., May 2008
67. Share of trials conducted in Poland in trials conducted by Merck&Co. in CEE, May 2008
68. Therapeutic areas of Merck&Co. trials conducted in CEE, May 2008
69. Number of clinical trials conducted in CEE by Johnson&Johnson, May 2008
70. Share of trials conducted in Poland and in CEE in all trials conducted by Johnson&Johnson, May 2008
71. Share of trials conducted in Poland in trials conducted by Johnson&Johnson in CEE, May 2008
72. Therapeutic areas of Johnson&Johnson trials conducted in CEE, May 2008
73. Number of clinical trials conducted in CEE by Amgen, May 2008
74. Share of trials conducted in Poland and in CEE in all trials conducted by Amgen, May 2008
75. Share of trials conducted in Poland in trials conducted by Amgen in CEE, May 2008
76. Therapeutic areas of Amgen trials conducted in CEE, May 2008
77. Number of clinical trials conducted in CEE by Wyeth, May 2008
78. Share of trials conducted in Poland and in CEE in all trials conducted by Wyeth, May 2008
79. Share of trials conducted in Poland in trials conducted by Wyeth in CEE, May 2008
80. Therapeutic areas of Wyeth trials conducted in CEE, May 2008
81. Time (in months) between trial acceptance and first patient visit in selected countries, 2007
82. Costs of conducting clinical trials in selected countries, 2007
83. Success of patient recruitment in clinical trials in Poland and Russia relative to US, 2002-2005
84. Success of patient recruitment in clinical trials in selected countries (number of patients per centre), 2007
85. Success of patient recruitment for clinical trials in selected European countries (number of patient per country)
86. Number of violations reported per 100 pages of the Clinical Research Form in selected CEE and other countries, 2007
87. Time (in days) needed to clarify concerns reported in the Clinical Research Form in selected CEE countries
88. FDA inspections carried out in CEE by year, 1994-2008
89. Findings of FDA inspections carried out in CEE, 1994-2008
90. Findings of FDA inspections conducted in selected CEE countries, 1994-2008
91. FDA inspection findings in Western Europe, CEE, and US, 1994-2008
92. Violations in CEE clinical trials reported after FDA inspections, 1994-2008
93. Most common violations reported in FDA inspections in Poland, Russia and Hungary, 1994-2008
94. Size of CEE clinical trials market (number of trials), 2000-2006
95. Number of clinical trials per one million inhabitants in selected CEE countries, 2000-2006
96. Average annual growth in number of clinical trials conducted CEE, 2000-2006
97. Number and y-o-y change of clinical trials conducted in Russia, 1994-2007
98. Number and y-o-y change of clinical trials conducted in Poland, 1994-2007
99. Number and y-o-y change of clinical trials conducted in the Czech Republic, 1994-2006
100. Number and y-o-y change of clinical trials conducted in Hungary, 1994-2007
101. Number and y-o-y change of clinical trials conducted in Slovakia, 1994-2006
102. Number and y-o-y change of clinical trials conducted in Romania, 1997-2005
103. Number and y-o-y change of clinical trials conducted in Ukraine, 1994-2005
104. Number and y-o-y change of clinical trials conducted in Bulgaria, 1996-2006
105. Quintiles’ sales revenues (PLN m) in Poland, 2006-2007
106. KCR’s sales revenues and net profits (PLN m), 2006-2007
107. Parexel’s global sales revenues on clinical trials ($ m), 2005-2007
108. MDS Pharma Services’ global sales revenues ($ m), 2005-2007
109. Covance’s global sales revenues and net profits ($ m), 2005-2007
110. PPD’s global revenues and net profit ($m), 2005-2007
111. Statutory deadline for processing applications to commence clinical trials in Poland, 2008
112. Procedure for registering a clinical trial in Poland, 2008
113. Types of liability applicable to clinical research and relevant legislation in Poland, 2008

List of tables

1. Comparison of trial conditions in Poland to conditions in Ukraine, Hungary and the Czech Republic, May 2008
2. Comparison of basic parameters of conducting clinical trials in Poland, Russia, Czech Republic, Romania, Turkey, Ukraine, Bulgaria, and Hungary, 2008
3. Minimum guaranteed sum of civil liability cover for researchers and sponsors of clinical trials in Poland, 2008