KCR: CEE Market for Clinical Trials
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Transcript of KCR: CEE Market for Clinical Trials
IS Central and Eastern Europe still an emerging market?
Anna Baran MdChief medical Officer, KCR S.A.
DisclaimerThe views and opinions expressed in the
following slides are those of the individual
presenter and should not be attributed to any
organization with which the presenter is
employed or affiliated.
These PowerPoint slides are the intellectual
property of the individual presenter and are
protected under the copyright laws of Poland.
Used by permission. All rights reserved.
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their respective owners.
PAGE / 2 Kcr seminar / stockholm, 18Jun / Anna Baran
AGENDA
PAGE / 3
Geopolitical status
European Commission and EMA adherence
CEE submission reality
CE bioequivalent studies – regional considerations
Cultural aspect – don’t assume
Conclusions
Kcr seminar / stockholm, 18Jun / Anna Baran
Geopolitical situation (2004)
Kcr seminar / stockholm, 18Jun / Anna BaranPage / 4
Kcr seminar / stockholm, 18Jun / Anna BaranPage / 5
Geopolitical situation (current)
EC directives and EMA adherence
Page / 6
EU Directive 2001/20 – implemented, Ukraine and Serbia
to follow
EU Directive 2005/28 – predominantly implemented
Approach to new CT regulation – under discussion
Adherence to EMA SA – case by case basis
EudraVigilance – implemented with few gaps
Kcr seminar / stockholm, 18Jun / Anna Baran
CEE Submission reality
Region-wide adherence to EU Directives
Strong focus on patients’ wellbeing
Increasing awareness of quality/pre-clinical data within
authorities
Page / 7 Kcr seminar / stockholm, 18Jun / Anna Baran
Description of feedbacks
Complexity of feedback from CEE authorities is increasing year by year, focusing now on subject matter review
PAGE / 8
Till 2010 2011 and on
Administrative deficiencies Stability data
Placebo related considerations Toxicology data
Irrelevant protocol Previous clinical data
Protocol design (medium level)
Kcr seminar / stockholm, 18Jun / Anna Baran
Regulatory process duration (kcr retrospective data)
Page / 9
0
20
40
60
80
100
120
140
160
180
200
RA average
approval
duration
EC average
approval
duration
Sequential
submission
Kcr seminar / stockholm, 18Jun / Anna Baran
Recommended approach
Page / 10
Include regulatory
perspective into study
feasibility
Design set up
timelines based
on retrospective
data
and recent
intelligence
Keep quality of the file
and stay conscious for
the next 60 days plus
Kcr seminar / stockholm, 18Jun / Anna Baran
Recently observed trends
Kcr seminar / stockholm, 18Jun / Anna Baran
Local agencies/study authorization
• Different level of recognition of clinicaldevelopment concept
Healthcare professionals
• Gradually increasing value recognition
Patients
• Open for change
Page / 11
Generic drugs – special cases
Page / 12
Bioequivalence to be proved based on non-PK data
Clinical endpoints often patient-reported
Placebo control as one of reference arms
Low treatment effect resulting in significant number of
subjects per group
Lack of ‚prejudice’ at drug agencies
Kcr seminar / stockholm, 18Jun / Anna Baran
CE bioequivalence development –benefits of stakeholders
Page / 13
•Ability to realize full program within single region
• Mastering CRO capability
•Access to non-reimbursed drugs under clinical trial
•Ability to join clinical research at relatively low complexity
•Lack of study type recognition
•Decreasing role of India
Regulatory landscape
Physicians perspective
CEE benefits
Patients perspective
Kcr seminar / stockholm, 18Jun / Anna Baran
Communication and conflict resolution style
Kcr seminar / stockholm, 18Jun / Anna BaranPage / 14
Risk propensity
Kcr seminar / stockholm, 18Jun / Anna BaranPage / 15
conclusions
CEE region is and will remain significant research market,
however ’emerging’ term is gradually moving East and
South
Upcoming laws can paradoxically prolong start-up
timeline
CE bioequivalence studies will challenge the standard
classification of research phases
Page / 14 Kcr seminar / stockholm, 18Jun / Anna Baran
QUESTIONS& ANSWERS
IS Central and Eastern Europe still an emerging market?Contact:
Anna Baran MD, Chief Medical Officer
Email: [email protected]
About KCR
KCR is a European Contract Research Organization (CRO) with a dynamic team of nearly
300 professionals operating across 18 countries in Europe as well as the U.S.
With 17 years of experience, more than 350 trials executed, over 30,000 patients recruited
and almost 3,000 sites contracted, KCR is a strategic solutions provider and a reliable
alternative to global CROs, delivering the all-important flexibility.
We provide services on long standing global or local contracts to 12 out of the Top 20
Global Pharma companies, and have been granted by 3 of them with the Preferred
Provider certification.
KCR offers clinical development support via 3 types of professional services:
- Full Service Model for Clinical Development Services (Phase I-IV)
- Functional Service Provider (FSP)
- Post-Marketing Clinical Services
For more information about the KCR offer, please visit www.kcrcro.com or contact us at
KCR
CORPORATE HEADQUARTERS.
6 Postepu str.
02-676 Warsaw, Poland
Phone: +48 22 313 13 13
Fax: +48 22 313 13 14
Email: [email protected]
www.kcrcro.com