ensuring fast patient enrollment by placing clinical trials in russia and ukraine
DESCRIPTION
Ensuring Fast Patient Enrollment by Placing Clinical Trials in Russia and Ukraine. Partnerships in Clinical Trials Russia-CIS 2013TRANSCRIPT
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Ensuring Fast Patient Enrollmentby Placing Clinical Trials in Russia
and Ukraine
Partnerships in Clinical Trials Russia-CIS2013
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Clinical Trials Industry in Russia and Ukraine
• The first international trial conducted in early 1990-s• Russia: 916 new clinical trials in 2012 - 60% increase
over 2011• 534 studies are ongoing in Russia• 219 studies ongoing in Ukraine• Clinical market in CIS to exceed €700m in 2014
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Clinical Trial Costs in Russia and Ukraine
• Shorter enrollment period• Lower PI grant expectations• Lower vendor costs• Hourly rates of clinical research specialists inthe region are twice lower than in the USA
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Investigator fees vary per region
Western Europe CIS Latin America Asia The USA0
1000
2000
3000
4000
5000
6000
7000
Average per patient investigator fee ($)
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FDA Inspections Since 2005Region Countries #Inspections NAI VAI OAI
CIS Russia, Ukraine, Georgia 82 69,5% 29,3% 1,2%
Europe All EU States 274 54,0% 45,6% 0,4%
The US United States 1759 48,7% 44,1% 7,2%
India India 33 54,5% 45,5% 0%
China China 13 38,5% 61,5% 0%
Middle East Israel, Turkey 26 34,6% 57,7% 7,7%
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High Quality Data in CIS Region
• GCP accepted as a National Standard• MDs must complete 6 years of med. school + 1-3
years of residency• MDs are re-certified each 5 years. • PI must be certified in the therapeutic area• Requirement of >5 years of experience for PI in
clinical trials• Highly qualified staff in CROs
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Quick Enrollment• Large patient population:
Russia – 143 MUkraine – 49 M
• 70% of population located in large cities• Centralized healthcare system• Increasing clinical infrastructure growth• Investigators eager• Established patients’ databases• Patients see trials as opportunity• Large % of drug naïve patients• Fewer competing trials
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75% of studies approved in 2012 in Russia are conducted in 8 therapeutic areas:
On-cology(110)
Pul-monolog
y(65)
Endocrinology(61)
Muscu-loskeletal dis-eases
(45)
Infec-tious
diseases(45)
Cardi-ology(42)
GE (35)
Psychiatry(32)
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Ensuring Fast Enrollment Through Feasibility
• Is the disease under study relevant to the patient population?
• Is the study design, comparators, and subjects’ visits acceptable?
• What are the anticipated Regulatory and Ethical challenges?
• What are the general timelines for study approval and site start-up?
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Acceptance of Protocol design
• Is comparator drug registeredin Russia and Ukraine?
• Is comparator drug used in Russiaand Ukraine as SOC?
• Is specific equipment availableat sites?
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Phase I studies in Russia
• Phase I in healthy volunteers studies of medications produced outside of Russia are forbidden in accordance with FZ-61
• “1) to establish safety and/or tolerance of medicinal products for healthy volunteers, except for the trials of medicinal products manufactured outside the Russian Federation;”
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Pre-clinical Studies for Generics
• Comparative acute toxicity in rodents• Comparative sub-acute toxicity in
rats/rabbits/dogs
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No Scientific AdviseWays to get opinion from Regulators
Unofficial expert advice
• No guarantees
• Not legal
• Quick
Official comments after CTA decline
• Official and legal
• Time consuming
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No official guidelines
• No definition for biosimilar drugs
• No official documents describing regulatory requirements for the quality, pre-clinical and clinical studies for biosimilars
But:
Biosimilar and biobetter drugs are under development in Russia
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WHAT ARE THE GENERAL TIMELINES FOR STUDY APPROVAL
AND SITE START-UP?
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Average time from application submission to final study approval (days)
Regulatory approval timelines
Estonia
Lithuania
Latvia
Bulgaria
Belarus
Ukraine
Russia
30 60 90 1200
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Case Study. Ovarian Cancer
• FDA and EMA-controlled study• Multinational phase III study of a
chemotherapy agent in women with ovarian cancer
• 600 patients enrolled in Russia, Ukraine, Belarus, Latvia, Lithuania and Bulgaria within a 3,5 year timeline
• Due to the law recruitment rates in Western Europe, Russia was requested to enroll extra 60 Pts.
• Total: 658 patients at 70 sites
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Case Study. Ovarian Cancer
0
100
200
300
400
500
600
700Enrolment within 3,5 years
6 CEE Countries 8 Western-EU Countries