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Confidential – For Internal Use Only
CLINICAL TRIAL CONDUCT IN
EMERGING MARKETS
How Do You Get To Maximum
Value In A Scalable Manner?
Confidential – For Internal Use Only
Success Factors For Clinical Research
| Clinical Trial Conduct in Emerging Markets 2
Quality
Speed
Cost
Quality is key in complex trials
Confidential – For Internal Use Only
CEE Quality – FDA Inspections
| Clinical Trial Conduct in Emerging Markets 3
0
10
20
30
40
50
60
70
80
90
100 NAI 42,7%
VAI 52,7%
OAI 4,6%
US
306 inspections between 1988-2012 in CEE
99% no or voluntary action indicated
Source: www.fda.gov
Outcome from Inspections per Country
Confidential – For Internal Use Only
Quality of Data: Query Rate
| Clinical Trial Conduct in Emerging Markets 4
Query Rates Comparison - Developed vs Emerging Global Regions
A Query rates normalised to the number of CRF pages
B Query rates normalised to the number of data parameters
Based on data from ACRO (2005-2010): 26 phase II/III conducted globally: 4,721 sites and 63,871 pts
No statistically significant difference between regions or in comparison to
North America in overall query rates or in database changes
Source: DIA Journal 2012 46:45 http://dij.sagepub.com/
Confidential – For Internal Use Only
What Drives Patient Enrollment?
| Clinical Trial Conduct in Emerging Markets 5
1. Site selection
2. Site start up
3. Patient recruitment
• Highly trained, enthusiastic investigators motivated to
follow GCP
• Easy access to patients
Confidential – For Internal Use Only
Project Operational Delivery
► Where to go…
► What is your priority
►Quick start up?
►Fast recruitment?
►Specific target patient population?
►Selected therapeutic area?
| Clinical Trial Conduct in Emerging Markets 6
A flexible, study-specific strategy is key
Confidential – For Internal Use Only
CEE: Is There a Start-Up Advantage?
| Clinical Trial Conduct in Emerging Markets 7
Slovakia vs Belgium 2013
0
50
100
150
200
250
300
350
1 2 3 4 5 6 7 8 9 10 11 12
2013
Month
Ave
rage
IP
Cycle
Tim
e (
Da
ys)
Slovakia Belgium
Slovakia can be a key country to deliver FPI
Confidential – For Internal Use Only
Countries With Quick Start-Up
Baltic States: Estonia, Latvia & Lithuania
► RA 30-60 days
► Well established clinical research market
80 new clinical trials applications/year
► Therapeutic areas: oncology, neurology/psychiatry,
endocrinology
►Cardiovascular – one of the highest mortality
rates in EU; medicines consumed 40, 9%
| Clinical Trial Conduct in Emerging Markets 8
Smaller, less known countries can be a strategic piece
in the puzzle
Confidential – For Internal Use Only
Therapeutic Category Consistency
| Clinical Trial Conduct in Emerging Markets 9
TA categories in CEE align with established markets –
but understanding local treatment standards is key
Confidential – For Internal Use Only
Why Russia and Ukraine For Clinical Trials?
| Clinical Trial Conduct in Emerging Markets 10
Metastatic Diffuse Gastric Cancer
0
50
100
150
200
250
Ukra
ine
Ru
ssia
Spain
Bra
zil
Un
ited S
tate
s
Hu
nga
ry
Italy
Pola
nd
Esto
nia
Ro
man
ia
South
Afric
a
Me
xic
o
Arg
entin
a
Bulg
aria
Portu
gal
Un
ited K
ing
dom
Isra
el
Germ
any
Cro
atia
Belg
ium
# P
ati
en
ts S
cre
en
ed
/Ran
do
mis
ed
Country
Enrolment by Country
# Patients Screened # Patients Randomized
• Rare histopathological type
• Chemotherapy-naive population
• Significant number of patients
Over 50% patients enrolled in Russia and Ukraine
Confidential – For Internal Use Only
Are Longer Start-Up Timelines a Viable Option?
| Clinical Trial Conduct in Emerging Markets 11
Metastatic Gastric Cancer Patient Enrolment
Between 2011 and 2013
Ukraine
US
Spain
Russia
HungaryPoland
2011 Enrollment Leaders
Ukraine
Russia
Spain
Italy
USBrazil
Romania
2012 Enrollment Leaders
Ukraine
RussiaSpain
US
Italy
Brazil Hungary
Life of Study Enrollment Leaders2011 Enrolment Leaders 2012 Enrolment Leaders Life of Study Enrolment Leaders
Countries with large patient populations: high recruitment
rates can help compensate for longer start-up timelines
Confidential – For Internal Use Only
What is the Value of Smaller Countries?
| Clinical Trial Conduct in Emerging Markets 12
Patient Enrolment - Cardiovascular Study
study completed
Romania and Slovakia provided 30% of total patients
Confidential – For Internal Use Only
What Makes Deep Local Expertise Important?
| Clinical Trial Conduct in Emerging Markets 13
Diabetes Mellitus Program – Site Selection
Romania
0
10
20
30
40
50
60
Sep-13 Oct-13 nov.13 Dec-13 jan.14 Feb-14
Nu
mb
er
of
sit
es s
ele
cte
d
Bulgaria
Czech Republic
Germany
Hungary
Lithuania
Poland
Romania
Russia
Slovakia
Spain
Ukraine
UK
Romania can be a key contributor to your diabetes studies
Confidential – For Internal Use Only
Last But Not Least…
| Clinical Trial Conduct in Emerging Markets 14
Trial Cost
Confidential – For Internal Use Only
Europe: Relative Clinical Study Costs
| Clinical Trial Conduct in Emerging Markets 15
Relative per Visit Cost in Selected CEE Countries, 2010-2011
100
77
67
59 5955
4946
44 44 44 43
0
10
20
30
40
50
60
70
80
90
100
UK
Cze
ch R
ep
Slo
vak
Rep
Est
on
ia
Ru
ssia
Po
lan
d
Bu
lgar
ia
Ro
man
ia
Lith
uan
ia
Ukr
ain
e
Hu
ng
ary
Tu
rkey
Clinical studies in CEE still cost less than UK or US
Source: PAREXEL’s Bio/Pharmaceutical R&D Sourcebook 2012/2013, Business Insights Ltd
Confidential – For Internal Use Only
An Affordable Approach to Extend Your Reach
| Clinical Trial Conduct in Emerging Markets 16
Indexed (vs. US) cost per patient, 2010-2011
0 20 40 60 80 100
North America
Western Europe
Latin America
Asia
Central Europe
Source: PAREXEL’s Bio/Pharmaceutical R&D Sourcebook 2012/2013, Business Insights Ltd
CEE offers competitive value, and costs are holding flat compared to other emerging regions
Confidential – For Internal Use Only
In Summary
► Emerging markets offer high quality combined with value
at competitive cost
► Key success factors:
►Define your priorities: a dialogue can help
►Client-specific, flexible and creative solutions required
| Clinical Trial Conduct in Emerging Markets 17
Confidential – For Internal Use Only
For more information,
visit www.covance.com
| Clinical Trial Conduct in Emerging Markets 18
