CLINICAL TRIAL CONDUCT IN EMERGING MARKETS How Do You Get To - - PowerPoint PPT Presentation

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Jan 21, 2023 9 likes •196 views

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 Speed Cost Quality Quality is key in complex trials 2 | Clinical

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CLINICAL TRIAL CONDUCT IN EMERGING MARKETS

How Do You Get To Maximum Value In A Scalable Manner?

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Success Factors For Clinical Research

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Quality Speed Cost Quality is key in complex trials

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CEE Quality – FDA Inspections

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10 20 30 40 50 60 70 80 90 100

NAI 42,7% VAI 52,7% OAI 4,6%

306 inspections between 1988-2012 in CEE 99% no or voluntary action indicated

Source: www.fda.gov

Outcome from Inspections per Country

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Quality of Data: Query Rate

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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/

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What Drives Patient Enrollment?

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1. Site selection 2. Site start up 3. Patient recruitment

Highly trained, enthusiastic investigators motivated to

follow GCP

Easy access to patients

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Project Operational Delivery

► Where to go… ► What is your priority

►Quick start up? ►Fast recruitment? ►Specific target patient population? ►Selected therapeutic area?

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A flexible, study-specific strategy is key

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CEE: Is There a Start-Up Advantage?

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Slovakia vs Belgium 2013

50 100 150 200 250 300 350 1 2 3 4 5 6 7 8 9 10 11 12 2013

Month

Average IP Cycle Time (Days) Slovakia Belgium

Slovakia can be a key country to deliver FPI

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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%

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Smaller, less known countries can be a strategic piece in the puzzle

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Therapeutic Category Consistency

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TA categories in CEE align with established markets – but understanding local treatment standards is key

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Why Russia and Ukraine For Clinical Trials?

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Metastatic Diffuse Gastric Cancer

50 100 150 200 250 Ukraine Russia Spain Brazil United States Hungary Italy Poland Estonia Romania South Africa Mexico Argentina Bulgaria Portugal United Kingdom Israel Germany Croatia Belgium

# Patients Screened/Randomised 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

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Are Longer Start-Up Timelines a Viable Option?

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Metastatic Gastric Cancer Patient Enrolment Between 2011 and 2013

Ukraine US Spain Russia Hungary Poland

2011 Enrollment Leaders

Ukraine Russia Spain Italy US Brazil Romania

2012 Enrollment Leaders

Ukraine Russia Spain US Italy Brazil Hungary

Life of Study Enrollment Leaders

2011 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

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What is the Value of Smaller Countries?

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Patient Enrolment - Cardiovascular Study study completed

Romania and Slovakia provided 30% of total patients

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What Makes Deep Local Expertise Important?

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Diabetes Mellitus Program – Site Selection

Romania

10 20 30 40 50 60

Sep-13 Oct-13 nov.13 Dec-13 jan.14 Feb-14 Number of sites selected Bulgaria Czech Republic Germany Hungary Lithuania Poland Romania Russia Slovakia Spain Ukraine UK

Romania can be a key contributor to your diabetes studies

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Last But Not Least…

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Trial Cost

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Europe: Relative Clinical Study Costs

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Relative per Visit Cost in Selected CEE Countries, 2010-2011

100 77 67 59 59 55 49 46 44 44 44 43

10 20 30 40 50 60 70 80 90 100

UK Czech Rep Slovak Rep Estonia Russia Poland Bulgaria Romania Lithuania Ukraine Hungary Turkey

Clinical studies in CEE still cost less than UK or US

Source: PAREXEL’s Bio/Pharmaceutical R&D Sourcebook 2012/2013, Business Insights Ltd

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An Affordable Approach to Extend Your Reach

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Indexed (vs. US) cost per patient, 2010-2011

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

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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

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For more information, visit www.covance.com

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