Ensuring Fast Patient Enrollment by Placing Clinical Trials in Russia and Ukraine. Partnerships in Clinical Trials Russia-CIS 2013

1. Ensuring Fast Patient Enrollment
by Placing Clinical Trials in Russia
and Ukraine
Partnerships in Clinical Trials Russia-CIS
2013

2. OCT: CRO in Russia,
Central and Eastern Europe

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 €700m in 2014

4. What is expected by global partners?

5. Overall Indexed Clinical Trial Costs

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 – 143 M
Ukraine – 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

11. Number of Clinical Trials
Russia
Ukraine

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
subjects’ 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?

15. Global rates of cardiovascular disease

16. Global rates of Rheumatoid Arthritis

17. Incidence of Stomach Cancer in Males

18. IS THE STUDY
DESIGN, COMPARATORS
ACCEPTABLE?

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
• “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;”

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

29. Questions