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Clinical trials in Poland 2010

Development forecasts for 2010-2012


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 		Date: 2010-04-14
Language: English or Polish
No. pages: 175
Delivery: PDF file
Clinical trials in Poland 2010
  description    |    table of contents    |    table of graphs and tables    |    leaflet    |    free article    |    request more info 

Description:

The third edition of this successful report presents a comprehensive study of the clinical trials sector in Poland . It offers a unique opportunity to keep track of current and anticipated situation on the market along with market trends. It explains the legal framework regulating the clinical trials market and concludes with development forecasts for the period until 2012.

The report presents:
  • key facts regarding the market size and its condition
  • most important aspects of the clinical trials sector in Poland
  • description of the circumstances affecting the sector in the previous years
  • information on the market growth opportunities and obstacles
  • profiles of CROs conducting clinical trials in Poland

The publication comprises results of the third edition survey of the major pharmaceutical corporations active in the clinical trials sector in Poland, analyzing main operations through a number of trials, their location and various therapeutic areas.

The report includes crucial information on legal conditions regulating the market and is an indispensable source of market analysis and industry data for:
  • Clinical Research Organisations (CROs) and pharmaceutical companies interested in launching their operations in Poland or cooperating with their Polish counterparts
  • Senior management executives of pharmaceutical companies in Poland and the CEE region
  • Market analysts and industry consultants involved in the clinical trials sector in Poland
  • Service providers for the clinical trials sector, consulting and research firms, legal companies, government institutions and investment funds, monitoring the clinical trials sector in Poland.


Table of contents:

  1. Report methodology p. 13

  2. Executive summary p. 17

  3. Size of the clinical trials market in Poland in 2005-2012 p. 21

    • Major events and trends on the Polish clinical trials market in 2008-2010 p. 21
    • Expected trends and events in 2010-2012 p. 23
    • Value of the Polish clinical trials market in 2005-2012 p. 24
    • Number of clinical trials conducted in Poland in 1994-2009 p. 25

  4. Results of survey of 100 companies conducting clinical research in Poland p. 27

    • Introduction p. 27
    • Evaluation of current situation on Polish clinical research market p. 28
    • Development forecasts for Polish clinical trials market p. 30
      • Predictions for the coming 12 months p. 30
      • Growth in patient number in 2010 p. 32
      • Growth in market size in 2010 and 2011 p. 33
      • Trends anticipated for the Polish clinical trials market p. 35
        • Sites of non-commercial clinical trials p. 35
        • Poland's competitiveness relative to other CEE countries p. 36
        • Organisation of phase I trials p. 37
        • Other trends anticipated for the Polish clinical trials market p. 37
    • Opportunities for and obstacles to expansion of clinical research market in Poland p. 39
    • Anticipated legal changes with a positive effect on the market p. 43
    • Clinical trial registration in Poland p. 45
      • Assessment of CEBK p. 45
      • Average trial registration time p. 46
      • Assessment of the impact of Ordinance of 2008 on documents submitted in connection with clinical trial registration p. 47
      • Ideas for facilitating clinical trial registration in Poland p. 48
    • Profiles and market situation of firms conducting clinical research in Poland p. 50
      • Number of clinical trials conducted p. 50
      • Number of patients participating in trials p. 52
      • Main areas of interest of companies conducting clinical trials in Poland 52
        • Categories of drugs tested in 2009 p. 52
        • Therapeutic groups with best research prospects p. 53
      • Phases of clinical trials p. 54
      • Financial standing p. 55
      • Firms with foreign investors p. 56
      • Revenue of companies conducting clinical trials in Poland p. 57
      • Length of experience of clinical research firms in Poland p. 58
      • Employment at CRO and pharma firms p. 59
      • Foreign operations p. 60

  5. Clinical trials conducted by international concerns in Poland p. 63

    • Number of clinical trials conducted p. 63
    • Clinical trial phases p. 64
    • Therapeutic categories p. 65
    • Analysis of clinical trials conducted by international concerns p. 66

  6. Profiles of selected CROs operating in the Polish market p. 91

    • International CROs p. 91
    • Polish CROs p. 99
    • SMO p. 107

  7. Comparative analysis of clinical research environment in Poland and selected other CEE countries p. 111

    • Legislation p. 111
    • Number of clinical trials conducted p. 113
    • Ethics committees p. 113
    • Registration of clinical trials p. 114
    • Selected CROs present in the market p. 116

  8. Inspections of clinical trials p. 117

  9. Assessment of Poland's potential as a site for clinical trials p. 121

    • Demographic trends p. 121
    • Epidemiological trends and the most frequent causes of death p. 123
      • Poland compared with other European countries p. 126
    • Medical personnel p. 128
    • Healthcare establishments p. 131
      • Number of hospitals p. 131
      • Number of hospital wards p. 132
      • Number of beds p. 133
      • Number of patients p. 135

  10. Legislative environment p. 137

    • Key legislation and institutions regulating clinical
    • research in Poland p. 137
    • Obtainment of clinical trials licence in Poland p. 139
      • Applying to commence clinical trials p. 139
      • Charges for filing applications for clinical
      • trial registration p. 143
      • Duration of application processing p. 143
      • Principle of "tacit consent" p. 144
      • Refusal to issue a license p. 144
    • Issuing opinions on clinical trials p. 145
      • Appplications to the bioethics committee p. 145
      • Fees for clinical trial opinions p. 147
      • Duration of application processing p. 148
    • Allocation of costs in clinical trials p. 148
    • VAT on clinical trials p. 149
    • Remuneration of investigators p. 150
    • Insuring clinical trials p. 151
    • Claims in clinical trials p. 152
    • Liability in clinical trials p. 154
      • Civil liability p. 154
        • Product liability p. 154
        • Liability in tort p. 155
        • Contractual liability p. 155
      • Criminal liability p. 155
      • Disciplinary responsibility p. 156
    • Personal data protection in clinical trials p. 156
      • Medical documentation p. 157
    • Clinical trials with minors p. 158
      • National standards p. 158
      • European standards p. 159
    • Planned changes to the clinical trials legislation p. 159
      • Clinical Trials Law p. 159
      • The Act on URPL p. 161
      • Amendments to the Pharmaceutical Law p. 162
        • Non-commercial clinical trials p. 162
        • Clinical trials inspections in Poland p. 163

  11. List of graphs p. 165

  12. List of tables p. 171

  13. About PMR p. 173

  14. Contact PMR p. 174

List of graphs and Tables:

List of graphs

  1. Value of clinical trials market in Poland (PLN m) and its y-o-y growth, 2005-2012
  2. Number of clinical trials conducted in Poland, 1994-2010
  3. Assessment of current situation on clinical research market in Poland, February 2010
  4. Main reasons for positive assessments of clinical trials market in Poland, February 2010
  5. Number of CROs/SMOs and clinical trial divisions of pharmaceutical companies in Poland, 2008 and 2010
  6. Will the situation in the clinical research sector in Poland deteriorate, improve or remain unchanged in 2010?, February 2010
  7. PMR Clinical Research Climate Indicator, September 2006-February 2010
  8. Will the number of patients participating in clinical trials increase, decrease or not change in 2010 relative to 2009?, February 2010
  9. In your opinion, by how much will the number of patients participating in clinical trails change in 2010 relative to 2009?, February 2010
  10. Will the Polish clinical trials market grow, contract or not change in relative to 2009?, February 2010
  11. In your opinion, by how much will the Polish clinical trials market value change in 2010 relative to 2009?, February 2010
  12. Will the Polish clinical trials market grow, contract or not change in relative to 2010?, February 2010
  13. In your opinion, by how much will the Polish clinical trials market value change in 2011 relative to 2010?, February 2010
  14. There will be more academic clinical trials in Poland in the future, 2008 and 2010
  15. Poland will be losing its competitive edge as a place to conduct clinical trials in CEE, 2008 and 2010
  16. More phase I trials will be organised in Poland, 2008 and 2010
  17. Trends anticipated over the next several years in the clinical trials market in Poland, February 2010
  18. Main barriers to growth of companies operating in clinical trials market in Poland, 2006, 2008 and 2010
  19. Key factors which could stimulate development of clinical trials market in Poland, 2006, 2008 and 2010
  20. Key legal changes which could speed up the growth of the clinical trials market's value in Poland, February 2010
  21. How would you assess CEBK's work in clinical trial registration in Poland, 2008 and 2010
  22. Average time it takes to register a clinical trial in Poland (no. of firms), February 2010
  23. Average time it takes to register a clinical trial in Poland (no. of days), 2008 and 2010
  24. Assessment of the impact of the November 2008 Ordinance on documents submitted in connection with registration of clinical trials on trial registration procedure in Poland, February 2010
  25. What could speed up clinical trial registration procedure in Poland?, February 2010
  26. How many trials did your company conduct in Poland in 2009?, February 2010
  27. Plans of pharmaceutical companies and CROs conducting clinical trials in Poland regarding the number of trials in 2010 relative to 2009, February 2010
  28. Average number of clinical trials conducted by pharmaceutical companies and CROs in Poland, 2009 and 2010
  29. Number of patients involved in clinical trials for the average company in Poland, 2009-2010
  30. Therapeutic groups subject to research in Poland (% of firms engaging in a given type of trial), 2009
  31. What therapeutic groups will be increasingly tested in clinical trials in Poland?, 2008 and 2010
  32. Phases of clinical trials conducted in Poland, 2009
  33. Assessment of the current financial standing of your clinical research firm in Poland relative to a year earlier, 2008 and 2010
  34. Respondents' predictions on financial standing of their clinical research firms in Poland for the next 12 months, 2008 and 2010
  35. Polish and foreign CROs operating on the clinical trials market in Poland, February 2010
  36. Polish and foreign pharmaceutical companies operating on the clinical trials market in Poland, February 2010
  37. Revenue of pharmaceutical companies conducting clinical trials in Poland, 2009
  38. Revenue of CROs operating in Poland, 2009
  39. Number of years your company has been present on the Polish clinical trials market, February 2010
  40. Headcount in pharmaceutical companies conducting clinical trials in Poland, 2009
  41. Headcount in CROs operating in Poland, 2009
  42. Does your firm organise clinical trials outside of Poland?, February 2010
  43. Number of clinical trials conducted by international pharmaceutical concerns in Poland, January 2010
  44. Clinical trials conducted by international pharmaceutical concerns in Poland, by phase, January 2010
  45. Clinical trials conducted by international pharmaceutical concerns in Poland, by therapeutic category, January 2010
  46. Number of clinical trials conducted by XXX in Poland relative to other CEE countries, January 2010
  47. Clinical trials conducted by XXX in Poland, by phase, January 2010
  48. Clinical trials conducted by XXX in Poland, by phase, January 2010
  49. Clinical trials conducted by XXX in Poland, by therapeutic category, January 2010
  50. Clinical trials conducted by XXX in Poland, by therapeutic category, January 2010
  51. Number of clinical trials conducted by XXX in Poland relative to other CEE countries, January 2010
  52. Clinical trials conducted by XXX in Poland, by phase, January 2010
  53. Clinical trials conducted by XXX in Poland, by therapeutic category, January 2010
  54. Number of clinical trials conducted by XXX in Poland relative to other CEE countries, January 2010
  55. Clinical trials conducted by XXX in Poland, by phase, January 2010
  56. Clinical trials conducted by XXX in Poland, by therapeutic category, January 2010
  57. Number of clinical trials conducted by XXX in Poland relative to other CEE countries, January 2010
  58. Clinical trials conducted by XXX in Poland, by phase, January 2010
  59. Clinical trials conducted by XXX in Poland, by therapeutic category, January 2010
  60. Clinical trials conducted by XXX and its subsidiaries in Poland, January 2010
  61. Number of clinical trials conducted by XXX in Poland relative to other CEE countries, January 2010
  62. Clinical trials conducted by XXX in Poland, by phase, January 2010
  63. Clinical trials conducted by XXX in Poland, by therapeutic category, January 2010
  64. Number of clinical trials conducted by XXX in Poland relative to other CEE countries, January 2010
  65. Clinical trials conducted by XXX in Poland, by phase, January 2010
  66. Clinical trials conducted by XXX in Poland, by therapeutic category, January 2010
  67. Number of clinical trials conducted by XXX in Poland relative to other CEE countries, January 2010
  68. Clinical trials conducted by XXX in Poland, by phase, January 2010
  69. Clinical trials conducted by XXX in Poland, by therapeutic category, January 2010
  70. Number of clinical trials conducted by XXX in Poland relative to other CEE countries, January 2010
  71. Clinical trials conducted by XXX in Poland, by phase, January 2010
  72. Clinical trials conducted by XXX in Poland, by therapeutic category, January 2010
  73. Number of clinical trials conducted by XXX in Poland relative to other CEE countries, January 2010
  74. Clinical trials conducted by XXX in Poland, by phase, January 2010
  75. Clinical trials conducted by XXX in Poland, by therapeutic category, January 2010
  76. Number of clinical trials conducted by XXX in Poland relative to other CEE countries, January 2010
  77. Clinical trials conducted by XXX in Poland, by phase, January 2010
  78. Clinical trials conducted by XXX in Poland, by therapeutic category, January 2010
  79. Number of clinical trials conducted by XXX in Poland relative to other CEE countries, January 2010
  80. Clinical trials conducted by XXX in Poland, by phase, January 2010
  81. Clinical trials conducted by XXX in Poland, by therapeutic category, January 2010
  82. XXX' revenue and net profit (PLN m) in Poland, 2004-2008
  83. XXX's revenue and net profit (PLN m) in Poland, July 2003-June 2008
  84. XXX's revenue and net profit (PLN m) in Poland, 2004-2007
  85. XXX's revenue and net profit/loss (PLN m) in Poland, 2007-2008
  86. XXX' revenue and net profit/loss (PLN m) in Poland, 2004-2008
  87. XXX's revenue and net profit/loss (PLN m), 2004-2008
  88. XXX's revenue and net profit (PLN m), 2005-2007
  89. XXX' revenue and net profit (PLN m) in Poland, 2007-2008
  90. Number of clinical trials conducted by XXX, 2000-2008
  91. XXX's revenue and net profit (PLN m), 2004-2008
  92. XXX's revenue and net profit/loss (PLN '000) in Poland, 2003-2008
  93. Number of clinical trial inspections carried out by the XXX in Poland, 1994-2009
  94. Results of inspections of clinical trials conducted by the XXX in Poland, 1994-2009
  95. Deficiencies identified during inspections of clinical trials conducted in Poland by the XXX, 1994-2009
  96. Results of clinical trial inspections carried out by the XXX in Poland compared to the results of inspections in other CEE countries, 1994-2009
  97. Results of XXX inspections in Poland compared to the results of inspections in other CEE countries, Western European countries and the US, 1994-2009
  98. Poland's population (million), 2004-2035
  99. Population forecast for selected age groups in Poland (million), 2004-2035
  100. Most frequent causes of death in Poland, 2008
  101. Incidence of malignant tumours among men in Poland, by type of cancer, 2007
  102. Incidence of malignant tumours among women in Poland, by type of cancer, 2007
  103. Deaths from malignant tumours among men in Poland, by type of cancer, 2007
  104. Deaths from malignant tumours among women in Poland, by type of cancer, 2007
  105. Surplus mortality in persons aged 25-64 in Poland relative to EU-27 average, by cause of death and gender, 1999 and 2006
  106. Surplus mortality in persons aged 25-64 in Poland relative to EU-27 average, by disease and gender, 2006
  107. Incidence of HBV and HCV infection (per 100,000 population) in Poland and in other selected European countries, 2007
  108. Health problems occurring in Poland compared to the European average, 2008
  109. Number of specialist doctors in Poland, by specialisation, 2008
  110. Salaries of doctors, midwives and nurses in Poland (PLN '000, gross), June 2008
  111. Number of public and non-public hospitals in Poland, by voivodship, 2008
  112. Number of hospital wards in Poland, by specialisation, 2008
  113. Number of beds in public and non-public hospitals in Poland ('000), by voivodship, 2008
  114. Number of beds in hospitals in Poland, by ward, 2008
  115. Number of patients treated in hospitals in Poland ('000), by ward, 2008
  116. Procedure for registering a clinical trial in Poland, 2008
  117. Statutory deadline for processing applications to commence clinical trials in Poland, 2008
  118. 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 Hungary, United States, the Czech Republic, Russia, India, United Kingdom and Germany, February 2010
  2. Description of clinical trials conducted by XXX in Poland, 2010
  3. Description of clinical trials conducted by XXX in Poland, 2010
  4. Description of clinical trials conducted by XXX in Poland, 2010
  5. Description of clinical trials conducted by XXX in Poland, 2010
  6. Description of clinical trials conducted by XXX in Poland, 2010
  7. Description of clinical trials conducted by XXX in Poland, 2010
  8. Description of clinical trials conducted by XXX in Poland, 2010
  9. Description of clinical trials conducted by XXX in Poland, 2010
  10. Description of clinical trials conducted by XXX in Poland, 2010
  11. Description of clinical trials conducted by XXX in Poland, 2010
  12. Description of clinical trials conducted by XXX in Poland, 2010
  13. Description of clinical trials conducted by XXX in Poland, 2010
  14. Description of clinical trials conducted by XXX in Poland, 2010
  15. Description of clinical trials conducted by XXX in Poland, 2010
  16. Description of clinical trials conducted by XXX in Poland, 2010
  17. Number of clinical trials conducted by XXX in Poland, by therapeutic area and number of participants, 1999-2009
  18. Description of clinical trials conducted by XXX in Poland, 2010
  19. Description of clinical trials conducted by XXX in Poland, 2010
  20. Description of clinical trials conducted by XXX in Poland, 2010
  21. Key legal acts regulating the conduct of clinical trials in Poland and in other selected other CEE countries, 2010
  22. Number of clinical trials conducted in Poland and in other selected CEE countries, 2010
  23. Rules of conduct for ethics committees in Poland and in other selected CEE countries, 2010
  24. Registration of clinical trials in Poland and in other selected CEE countries, 2010
  25. Selected CROs operating in the clinical trials market in Poland and in other selected CEE countries, 2010
  26. Qualified medical doctors and doctors working at healthcare institutions in Poland, 2008
  27. Documents provided with the application to the Ministry of Health for clinical trial authorisation - the current state compared with the previous lists of required documents, 2010
  28. Documents provided with the application for a bioethics committee opinion on a clinical trial, the current state compared with the previous lists of required documents, 2010
  29. Minimum guaranteed sum of civil liability cover for researchers and sponsors of clinical trials in Poland, 2010

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