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Clinical and Regulatory Environment in Russia and Eastern Europe

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Current clinical and regulatory environment in Russia for conducting clinical research. Overview specific regulatory requirements, investigative sites and healthcare. Presentation originated in 2012

Publicada em: Saúde e medicina, Negócios
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Clinical and Regulatory Environment in Russia and Eastern Europe

  1. 1. Clinical and Regulatory Environment in Russia and Eastern Europe Aleksandar Skuban, M.D. August 2012| Philadelphia
  2. 2. disclosure All images used with permission: www.istockphoto.com or as noted 2
  3. 3. I took a speed-reading course and read War and Peace in twenty minutes. It involves Russia. Woody Allen
  4. 4. Pharmaceutical R&D and Global CROs Emerging Markets Development Clinical Drug Development in Psychiatry Background Eastern Europe and United States Phase II-III global studies including: Russia, Serbia, Croatia, Hungary, Romania, Bulgaria, Ukraine, Czech Republic, Slovakia, Poland, Estonia, Slovenia
  5. 5. Your Experience in CEE Expectations 5
  6. 6. Presentation Overview 6
  7. 7. Overview of Central and Eastern Europe* Baltic States Estonia Lithuania Latvia Commonwealth of Independent States (CIS) Russian Federation Ukraine BelarusGeorgia Kazakhstan (…) Moldova 7 Central Europe Czech Republic Poland SlovakiaHungary Slovenia Croatia Balkans Serbia Montenegro FYR MacedoniaRomania Bulgaria Bosnia and Herzegovina *not all countries in region listed
  8. 8. Ongoing Phase 2&3 Studies (n=4832) 2611 390* 840 173 71 354 US Russia Germany Ukraine Serbia Hungary Number of Trials Open industry-sponsored studies at www.clinicaltrials.gov as of 5 August 2012 8 * 63 ongoing pediatric trials
  9. 9. Active Phase 1 Trials (n=2043) 1230 159 25 5 2 16 US Germany Russian Federation Ukraine Serbia Hungary Number of Trials Open studies at www.clinicaltrials.gov as of 5 August 2012 9
  10. 10. Regional Considerations for Global Development Access to Population with Target Disease Diagnostic Reliability Compatible Treatment Paradigms Competent Sites & Data Quality Regulatory and Ethics Framework Recruitment Speed, Cost, Infrastructure 10
  11. 11. Eastern Europe in Clinical Research: The first 10 years 11Dept. HHS OIG: The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects (September 2001 OEI-01-00-00190) pp.10 Table 2
  12. 12. New Global Trials Initiated in CEE* 146 213 196 62 47 204 573 725 212 375 Hungary Poland Russia Romania Ukraine 2002 2007 Center Watch Data August 2008 (*selected countries)
  13. 13. Growth Rate of New Global Trials Initiated in CEE* Center Watch Data August 2008 (*selected countries)
  14. 14. Approved marketing applications FY2008 (FDA): Source of Subjects Drugs Biologics Foreign and domestic subjects 92,859 206,842 Percentage of foreign subjects 56.9% 86.9% Foreign and domestic trial sites 11,227 717 Percentage of foreign trial sites 54.6% 49.7% 14 Source: "Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials," Dept. of Health and Human Services Office of Inspector General, June (oig.hhs.gov/oei/reports/oei- 01-08-00510.pdf)
  15. 15. Approved marketing applications FY2008 (FDA): Source of Foreign SubjectsDrugs Biologics Number of foreign subjects 52820 179712 WE, AU, Japan, NZ, CAN 32761 (62%) 109706 (61%) New EU members 5474 (10%) 1062(0.5%) Emerging Countries (BRICM) 4789 (9%) 19888 (11%)* Number of Countries 68 38 15 Data from : "Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials," Dept. of Health and Human Services Office of Inspector General, June (oig.hhs.gov/oei/reports/oei-01-08-00510.pdf) *No subjects from China or India
  16. 16. Leading physicians and Institutions Early adoption of GCP guidelines Excellent Data Quality High Patient recruitment Enthusiasm for international R&D collaboration “Rescue Studies” Evolving regulatory institutions Infrastructure challenges Skilled clinical research professionals Lower study costs
  17. 17. Russia In Global Clinical Research 17 CEE, CIS, BRIC, Asia, Emerging Country, Key Pharmaceutical Market
  18. 18. Russia: Key Facts Large, diverse, decreasing population: 143 m Geography across nine time zones Ethnically and culturally diverse country Centralized health care system Accessible patient population Research concentrated in Moscow, St. Petersburg 73% population in urban areas 18
  19. 19. Health Care in Russia 19
  20. 20. Health care expenditure 8.1 7.9 11.5 6 2560 1308 4011 583 United Kingdom* Hungary Switzerland Russian Federation US$ PPP2 % of GDP Source: WHO EU Atlas of Health 2008
  21. 21. Among Highest in Europe: Hospitals Beds and Physicians 304 397 431 896 833 806 792 568 966 Hungary Switzerland Russian Federation Hospital beds Nurses Physicians Per 100000 population Source: WHO Atlas of Health 2008 in Europe
  22. 22. Russia Health Statistics (WHO) 1st Deaths All Causes, CV, IHD, Pulmonary, Injury & Poisoning 2nd Deaths Cancer, Cerebrovascular, Suicide 3rd HIV New Cases Source: WHO Europe 2008
  23. 23. Russia Health Statistics (WHO) 2nd Highest % male smokers and spirits consumption Lowest life expectancy at birth for men (59 years) (Source: WHO Europe 2008)
  24. 24. Deaths from diseases of circulatory system 301.2 175.3 28.6 157.1 47.8 4.9 Russian Federation Hungary France Females Males Per 100 000 population (25-64 years) Source: WHO Atlas of Health 2008 in Europe 24
  25. 25. Deaths from cancer 224.5 301.2 86.8 123.3 157.1 102.5 Russian Federation Hungary Sweden Females Males Per 100 000 population (25-64 years) Source: WHO Atlas of Health 2008 in Europe 25
  26. 26. Regional Health Statistics *Per 100000 male population Source: WHO Atlas of Health 2008 in Europe 26 Hungary Russian Federation Ukraine Population(millio n) 10 142 46 Deaths All causes* 13th Highest (782.2*) 4th Circulatory System 12th Highest (762.2) 4th Ischemic HD 5th Highest (406.3) 2nd Cancer Highest (301.2) 2nd (224.5) Lung Cancer Highest (99.7) 5th 10th Suicide 5th (40) 2nd (56.1) 8th AIDS new cases Low (0.2) Low (0.6) Highest (9.7)
  27. 27. Regulatory Framework New Federal Drug Law “On Drugs Circulation” 1 Sep 2010 Local study required if no Russian patients in global Phase 3 program Need for local study may delay registration in Russia for 2-3 years 27 http://www.efgcp.eu/Downloads/EFGCPReportFiles/Russ ia%20definitive.pdf
  28. 28. Local Clinical Trial Requirements Local Patient Data Needed for New Products, Line Extensions, New Indications No specific guidance on design, type of study or required number of patients Guidance based on Expert feedback, Company expertize, informal discussions, industry benchmarks 28
  29. 29. Impact on Product Registration For timely product registration consider including Russian sites in Phase II-III trials Requirements for Local Regulatory Studies may further evolve Strategy for product launch in Russia 29
  30. 30. Local Ethics Committees (LECs) LEC at each investigative site Submission after Russian Ministry of Health approval Protocol & documents in Russian 2-4 weeks review cycle Some with executed clinical trial agreement Most LECs review without a fee 30
  31. 31. Clinical Investigative Sites 700000 physicians 1% involved in clinical studies 900 institutions accredited by Ministry of Health 31
  32. 32. Global Share of Sites and Patients Country Density* WW site share % United States 120.2 48.7 Germany 51.2 5.7 Japan 15.7 2.7 Russia 7.7 1.5 Hungary 62.5 0.8 Poland 30.9 1.6 32*number of recruiting sites/country population (m) Data selection from Thiers at al: “Trends in the globalization of clinical trials” Nature Vol.7, Jan 2008 (*as of April 12th 2007) 0.03% population in Russia participated in clinical studies in 2006
  33. 33. Russia in Global Clinical Trials CV outcome studies from 1990s: Patient Population and Expertize Notable Proof of Concept studies: Alzheimer’s Disease and Schizophrenia Current Phase II-III landscape: Oncology, CV, Diabetes, Respiratory, CNS In 2011 MoH issued 567 approvals- 370 for global studies 33
  34. 34. Opportunities and Challenges Enrollment Study Cost Execution Quality Site Qualification Diverse patient population Multi-specialty large medical centers New legislation Changing reg. environment Saturation of Good Sites Customs procedures Logistics Language Barrier Infrastructure POC Phase II Studies New Legislation34
  35. 35. In Sum Countries with Unique Advantages – Continue to Attract Clinical Research Opportunities Evolving regulations and Health Authorities: Local Clinical Trials for Product Registrations Experienced and well-qualified investigators: Increasing local and global competition for quality sites Build Own Expertise and Critically Evaluate Expectations On Regular Basis 35
  36. 36. Clinical and Regulatory Environment in Russia and Eastern Europe Aleksandar Skuban, M.D. August 15, 2012| Philadelphia Thank you

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