3. 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 âŹ700m in 2014
6. Clinical Trial Costs in Russia and Ukraine
⢠Shorter enrollment period
⢠Lower PI grant expectations
⢠Lower vendor costs
⢠Hourly rates of clinical research specialists in
the region are twice lower than in the USA
7. Investigator fees vary per region
0
1000
2000
3000
4000
5000
6000
7000
Western
Europe
CIS Latin America Asia The USA
Average per patient investigator fee ($)
8. FDA Inspections Since 2005
Region 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%
9. 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
10. Quick Enrollment
⢠Large patient population:
Russia â 143 M
Ukraine â 49 M
⢠70% of population located in large cities
⢠Centralized healthcare system
⢠Increasing clinical infrastructure growth
⢠Investigators eager
⢠Established patientsâ databases
⢠Patients see trials as opportunity
⢠Large % of drug naïve patients
⢠Fewer competing trials
12. 75% of studies approved in 2012 in Russia
are conducted in 8 therapeutic areas:
Oncology
(110)
Pulmonology
(65)Endocrinology
(61)
Musculoskele
tal diseases
(45)
Infectious
diseases
(45)
Cardiology
(42)
GE
(35)
Psychiatry
(32)
13. Ensuring Fast Enrollment Through
Feasibility
⢠Is the disease under study relevant to the
patient population?
⢠Is the study design, comparators, and
subjectsâ visits acceptable?
⢠What are the anticipated Regulatory and
Ethical challenges?
⢠What are the general timelines for study
approval and site start-up?
14. IS THE DISEASE UNDER STUDY
RELEVANT TO THE PATIENT
POPULATION?
19. Acceptance of Protocol design
⢠Is comparator drug registered
in Russia and Ukraine?
⢠Is comparator drug used in Russia
and Ukraine as SOC?
⢠Is specific equipment available
at sites?
20. WHAT ARE THE ANTICIPATED
REGULATORY AND ETHICAL
CHALLENGES?
21. Phase I studies in Russia
⢠Phase I in healthy volunteers studies of medications
produced outside of Russia are forbidden in
accordance with FZ-61
⢠â1) to establish safety and/or tolerance of medicinal
products for healthy volunteers, except for the trials
of medicinal products manufactured outside the
Russian Federation;â
22. Pre-clinical Studies for Generics
⢠Comparative acute toxicity in rodents
⢠Comparative sub-acute toxicity in
rats/rabbits/dogs
23. No Scientific Advise
Ways to get opinion from Regulators
Unofficial expert advice
⢠No guarantees
⢠Not legal
⢠Quick
Official comments after CTA decline
⢠Official and legal
⢠Time consuming
24. 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
25. WHAT ARE THE GENERAL TIMELINES
FOR STUDY APPROVAL
AND SITE START-UP?
26. Average time from application submission to final study approval (days)
Regulatory approval timelines
Estonia
Lithuania
Latvia
Bulgaria
Belarus
Ukraine
Russia
30 60 90 1200
27. 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
28. Case Study. Ovarian Cancer
0
100
200
300
400
500
600
700
Enrolment within 3,5 years
6 CEE Countries 8 Western-EU Countries