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Current environment for clinical trial conduct in Russia Contract management Mikhail A. Putilovskiy MD, PhD Clinical Operations Manager. Content. Opportunities and threats for CT conduct in Russia Regulatory, legal and accounting peculiarities of clinical trial contracting

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  1. Current environment for clinical trial conduct in RussiaContract managementMikhail A. Putilovskiy MD, PhDClinical Operations Manager

  2. Content • Opportunities and threats for CT conduct in Russia • Regulatory, legal and accounting peculiarities of clinical trial contracting • Investigators & Institution segmentation

  3. Environment: Opportunities (1) • Huge territory and population (141,9 million people) • Political stability • Centralized HC system • Established regulatory review process • Local GCP aligned with ICH GCP • Possibility of running placebo-controlled trials • FDA accepts data from CT conducted in RU only for product registration

  4. Environment: Opportunities (2) • High access to various patient population • High enrolment speed • High quality of data • Still considered as a mid/low-cost country with regards to investigator grants

  5. Environment: Threats and challenges • Growing cost of experienced staff on the market • Decrease in number of people with medical background coming to pharma industry • Growing competition in CT sector

  6. Content • Opportunities and threats for CT conduct in Russia • Regulatory, legal and accounting peculiarities of clinical trial contracting • Investigators & Institution segmentation

  7. Laws and Regulations influencing CT conduct and contracting in Russia • Federal Law “On Medicine” №86-ФЗ, of 22.06.1998 with amendments • National Standard of the Russian Federation GOST P 52379-2005 “Good Clinical Practice” • Order of Ministry of Health of Russian Federation №266 of 19.06.2003 “Procedures for Clinical Practice in Russian Federation”

  8. Direct payments to investigators are allowed: Federal Law “On Medicines” (based on amendments from 2004) National Standard (GOST) - GCP Direct payments to investigators are prohibited: Order of Ministry of Health – “Procedures for Clinical Practice in Russian Federation” Regulatory and legal peculiarities: contradictions in legislation?

  9. Direct payments to investigators are allowed: Clarification letter from AIPM Clarification letters from Ministry of Health and Federal Service (2004, 2005, 2009) Clarification letter from multinational legal firm (2009) Direct payments to investigators are prohibited: Clarification letters from 2 multinational legal firms (2004, 2005) Regulatory and legal peculiarities: contradictions in legislation?

  10. Regulatory and legal peculiarities • Final decision regarding way of contracting and payment in Russia is made internally by legal function of each pharmaceutical company and CRO

  11. Content • Opportunities and threats for CT conduct in Russia • Regulatory, legal and accounting peculiarities of clinical trial contracting • Investigators & Institution segmentation

  12. Federal level Federal State Institutions reporting to the Ministry of Health and Social Development:58 Research Institutes, Educational Institutes, specialized hospitals and clinics Federal State Institutions reporting to the Federal Medico-biological Agency:124 Research Institutes and specialized supporting agencies Scientific Institutions reporting to the Russian Academy of Medical Sciences:13 Research Institutes Regional level Hospitals and clinics under the umbrella of regional healthcare system Institution segmentation: Federal and Regional levels

  13. The majority of Institutions are located in Moscow and St. Petersburg and are lead by key OPLs Huge experience in clinical research Established Ethical review process Established logistics for CT conduct Decreasing enrolment speed and access to the patients Significant amount of ongoing trials Decreasing level of interest from the investigators Significant amount of time required for Contract negotiations with administrative departments (legal, planning, accounting) Peculiarities of Federal level sites

  14. The majority of sites are located outside of Moscow and St. Petersburg Less experience in clinical research, logistics for CT conduct isn’t always well established High enrolment speed and access to the patients High level of interest from the investigators Less complicated process of Contracts review Peculiarities of Regional level sites

  15. Key takeaways • There are still great opportunities for CT conduct in Russia • Final decision regarding way of contracting and payment in Russia is made internally by each pharmaceutical company and CRO • Careful site selection with appropriate balance between Federal and Regional sites is a key to success with future enrolment

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