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 Trial Conduct in Emerging Markets Confidential – For Internal Use Only
CEE Quality – FDA Inspections Outcome from Inspections per Country NAI 42,7% US 100 VAI 52,7% OAI 4,6% 90 80 70 60 50 40 30 20 10 0 306 inspections between 1988-2012 in CEE 99% no or voluntary action indicated Source: www.fda.gov 3 | Clinical Trial Conduct in Emerging Markets Confidential – For Internal Use Only
Quality of Data: Query Rate 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/ 4 | Clinical Trial Conduct in Emerging Markets Confidential – For Internal Use Only
What Drives Patient Enrollment? 1. Site selection 2. Site start up 3. Patient recruitment • Highly trained, enthusiastic investigators motivated to follow GCP • Easy access to patients 5 | Clinical Trial Conduct in Emerging Markets 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? A flexible, study-specific strategy is key 6 | Clinical Trial Conduct in Emerging Markets Confidential – For Internal Use Only
CEE: Is There a Start-Up Advantage? Slovakia vs Belgium 2013 350 Average IP Cycle Time (Days) 300 250 200 Slovakia Belgium 150 100 50 0 1 2 3 4 5 6 7 8 9 10 11 12 2013 Month Slovakia can be a key country to deliver FPI 7 | Clinical Trial Conduct in Emerging Markets 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% Smaller, less known countries can be a strategic piece in the puzzle 8 | Clinical Trial Conduct in Emerging Markets Confidential – For Internal Use Only
Therapeutic Category Consistency TA categories in CEE align with established markets – but understanding local treatment standards is key 9 | Clinical Trial Conduct in Emerging Markets Confidential – For Internal Use Only
Why Russia and Ukraine For Clinical Trials? Metastatic Diffuse Gastric Cancer Enrolment by Country 250 # Patients Screened/Randomised • Rare histopathological type 200 • Chemotherapy-naive population • Significant number of patients 150 100 50 0 Ukraine Russia Spain Brazil United States Hungary Italy Poland Estonia Romania South Africa Mexico Argentina Bulgaria Portugal United Kingdom Israel Germany Croatia Belgium Country # Patients Screened # Patients Randomized Over 50% patients enrolled in Russia and Ukraine 10 | Clinical Trial Conduct in Emerging Markets Confidential – For Internal Use Only
Are Longer Start-Up Timelines a Viable Option? Metastatic Gastric Cancer Patient Enrolment Between 2011 and 2013 2011 Enrolment Leaders 2012 Enrolment Leaders Life of Study Enrolment 2011 Enrollment Leaders 2012 Enrollment Leaders Life of Study Enrollment Leaders Leaders Romania Hungary Brazil Poland Brazil Hungary Italy US Ukraine Ukraine Ukraine Italy Russia US Spain Spain Spain Russia Russia US Countries with large patient populations: high recruitment rates can help compensate for longer start-up timelines 11 | Clinical Trial Conduct in Emerging Markets Confidential – For Internal Use Only
What is the Value of Smaller Countries? Patient Enrolment - Cardiovascular Study study completed Romania and Slovakia provided 30% of total patients 12 | Clinical Trial Conduct in Emerging Markets Confidential – For Internal Use Only
What Makes Deep Local Expertise Important? Diabetes Mellitus Program – Site Selection 60 50 Romania Number of sites selected 40 Bulgaria Czech Republic 30 Germany Hungary Lithuania 20 Poland Romania Russia 10 Slovakia Spain Ukraine 0 UK Sep-13 Oct-13 nov.13 Dec-13 jan.14 Feb-14 Romania can be a key contributor to your diabetes studies 13 | Clinical Trial Conduct in Emerging Markets Confidential – For Internal Use Only
Last But Not Least… Trial Cost 14 | Clinical Trial Conduct in Emerging Markets Confidential – For Internal Use Only
Europe: Relative Clinical Study Costs Relative per Visit Cost in Selected CEE Countries, 2010-2011 100 100 90 80 77 70 67 60 59 59 55 50 49 46 44 44 44 43 40 30 20 10 0 UK Slovak Rep Estonia Russia Poland Bulgaria Romania Lithuania Ukraine Hungary Turkey Czech Rep Clinical studies in CEE still cost less than UK or US Source: PAREXEL’s Bio/Pharmaceutical R&D Sourcebook 20 12/2013, Business Insights Ltd 15 | Clinical Trial Conduct in Emerging Markets Confidential – For Internal Use Only
An Affordable Approach to Extend Your Reach Indexed (vs. US) cost per patient, 2010-2011 Central Europe Asia Latin America Western Europe North America 0 20 40 60 80 100 Source: PAREXEL’s Bio/Pharmaceutical R&D Sourcebook 20 12/2013, Business Insights Ltd CEE offers competitive value, and costs are holding flat compared to other emerging regions 16 | Clinical Trial Conduct in Emerging Markets 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 17 | Clinical Trial Conduct in Emerging Markets Confidential – For Internal Use Only
For more information, visit www.covance.com 18 | Clinical Trial Conduct in Emerging Markets Confidential – For Internal Use Only
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