Patient Recruitment in Global Trials: Accessing Research Subjects in Developing Regions

1
Patient Recruitment in Global Trials Accessing
Research Subjects in Developing Regions
17th Annual Partnerships with CROs Track E
Outsourcing Globally and Executing International
Global Trials Wednesday, April 16, 2008
2
Panel

• Eileen Harvey, Vice President, Operations,
• PRA INTERNATIONAL
• Nancy A. Sacco, PhD, Senior Director, Global
  Head, Clinical Operations, TAKEDA PHARMACEUTICALS
• Thomas Smith, MD, Vice President, Global Medical
  Affairs, KENDLE INTERNATIONAL

3
Delay of Most Clinical Studies
Source CenterWatch 1998.
4
Trends in Subject Enrollment
Data from Nature January 2008
5
Trends in Subject Enrollment
Data from Nature January 2008 CenterWatch
analysis, FDA 2007
6
Key Countries in Global Trials
Source Wachovia Capital Markets, Initiating On
The Pharma Services Sector, Nov. 27, 2007
7
Patient Access
Allocation of development spending by global
region current
Expected development spending allocation by 2010
significant increase in A/P, ROW
Source Jefferies, CRO Survey, March 2007
7
8
Factors Driving Attractiveness

• Patient Pool
• Size and availability of suitable patients
• Cost effectiveness
• Cost of labor and facilities
• Number of suitable patients recruited per site
• Regulatory environment
• FDA perspective on data
• Regulatory laws and support for clinical trials
• Approval timelines

• Relative experience
• CROs and ability to monitor
• Clinical trials experience
• Size and availability of labor force
• Previous performance metrics
• Infrastructure and environment
• Healthcare infrastructure
• Country infrastructure
• Country risk factor

AT Kearney Country Attractiveness index for
clinical trials www.atkearney.com
9
Factors Involved in Country Selection
Quality
Medical Practice
Deciding where the trials will be managed
depends upon
Regulatory
Cost
Speed
Capacity
Commercial Value
10
Key Factors in Emerging Regions

• Patient pool
• Racial population mix
• Disease demographics
• Labor
• Supply, costs, competition
• Educational backgrounds
• Cost effectiveness
• Regulatory environment
• Intellectual Property
• Cultural considerations
• IC issues
• Language considerations

• IT considerations
• Relative experience
• Hospital infrastructure
• Treatment naïve concerns
• Clinical supply chain
• Central lab issues
• Understanding and experience with ICH and GCP
• Commercial interest
• Political stability

11
Asia-Pacific Regional Facts

• Population of 3.9 billion
• Provides patient access and overall cost
  effectiveness
• Excellent IT infrastructure
• Changing epidemiologies as cultures become more
  developed
• Positioning in Global Pharmaceutical Market

12
India Growing Sophisticated

• Improved clinical trial environment
• All therapeutic areas and phases
• Timely and high quality data
• Highly trained and experienced clinical
  resources
• Rapidly growing international pharma market
• Indian patent rules now similar to international
  regulations
• Regulatory approvals can be obtained in a short
  period of time

13
Ready Patient Access

• Vast and growing population
• Growing market and economic growth
• More people moving to the commercial workplace
• More receiving health insurance and demanding
  better healthcare
• Improvement in healthcare with economic growth
• Healthcare system
• Pay for medicine
• Village communities

14
A Relationship-Centered Culture

• Asia has a relationship-centered focus
• Family, extended family and village elders
• Word of mouth is the strongest DTP approach
• Community approaches for local inhabitants
• Health camps for undiagnosed patients
• Literacy levels need to be considered
• Patients struggle to understand expectations
• Education and communication are key

15
Success Factors in Asia Pacific

• Sites have large patient pools large hospital
  bases
• Motivated and engaged PIs have been key to
  recruitment
• Good site logistics
• Strong team who contact all potential patients in
  the respective institute
• Meetings with colleagues in the hospital
• Contact with colleagues to pool patients
• Pre-identify patients and line up ready to start
  screening
• Patient group meetings to introduce clinical
  trials to their patients and families and share
  experiences

16
Latin America

• Population 420MM
• 228MM Spanish
• 188MM Portuguese
• Mainly located in large cities
• Large pediatric population
• (130MM aged 0-14 years)
• Southern hemisphere for seasonal reversal
• Large metropolitan areas with specialized sites
• Very high recruitment and retention rates
• Sites that follow particular US EU guidelines
• High percentage of treatment naïve individuals

Equator
17
The Pros and Cons of Participation
Cons
Pros

• Benefits me/others
• Informs of all risks
• Benefits outweigh risks
• Might lead to cure
• Recommended by physician
• Advances science

• Could receive placebo
• Could have bad side effect
• Could lose treatment at end of study

Source US Bureau of the Census. 1996.
18
Approval Timelines
Submissions and approvals between 2001 and 2003
Source. CMR Regulatory environment in
emerging regions. Feb 2006.
19
Ex-US FDA-Regulated PIs Initiating Trials
Source Tufts CSDD Analysis of FDAs Bioresearch
Monitoring Information System File (BMIS)
20
Growth in ex-US FDA Regulated Investigators
Initiating Trials
Source Tufts CSDD Analysis of FDAs Bioresearch
Monitoring Information System File (BMIS)
21
High Growth Countries for New FDA-Regulated
Investigators
Source Tufts CSDD Analysis of FDAs Bioresearch
Monitoring Information System File (BMIS)
22
Key Points and Thoughts

• One from each presenter
• Now for the audience
• THOUGHTS
• COMMENTS
• CONCERNS
• EXPERIENCE

23

• Eileen Harvey
• Harveyeileen_at_praintl.com
• Nancy Sacco, PhD
• Nsacco_at_tgrd.com
• Thomas Smith, MD
• Smith.thomasb_at_kendle.com