Trends in role of emerging countries in finding subjecs for clinical trials

1. The Patient Recruitment Recruitment of Volunteers…
Challenges  Most under-estimated and most crucial part
of a human clinical study
Can Emerging Regions Help?
 Not planned early enough
Mukesh Kumar, PhD, RAC  “All eggs in one basket” syndrome
 Trouble-shooting verses Trouble-Prevention
Senior Director
Regulatory Affairs & Quality Assurance  One size fit all strategies
Amarex Clinical Research  Poorly planned
Germantown, MD 20874, USA  Recruitment strategies
mukeshk@amarexcro.com
 Expanding exposure
240-454-6835
www.amarexcro.com 2
Challenges to Recruitment Recruitment is Getting Harder
 Lack of patient pools  Too many trials
 Availability of competing treatments  Few experienced sites and investigators
 Standard of care available  Good standard of care (in US and
Western EU)
 Quality of life of patients
 Few truly innovative therapies (wonder
 Length and frequency of treatment
drugs)
 Public relations and public awareness
 Many high profile failures
Recruitment strategies are critical
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Emerging Regions of the World Emerging Regions are Pooled for
a Reason
Formerly known as the “Third World”
 Similar health-care infrastructure
 BRIC: Brazil, Russia, India and China
 Similar patient pools
 South-East Asia: Korea, Malaysia, etc.
 Similar economic conditions
 Other countries in South America
 Similar history of clinical trials
 Eastern Europe: Poland, Romania,
Ukraine, Serbia  Similar political and business
environments
 Africa (only for a few indications)
 Similar access to resources
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2. Role of Emerging Regions in Role of Emerging Regions in
Meeting Recruitment Goals Meeting Recruitment Goals
 Few trials Additional advantages:
 High rate of patient compliance
 Few investigators and sites (but rapidly
increasing)  Patients in dire need for standard
 Relatively limited availability of Western treatments
standard of care  “Few” regulatory hurdles (case-by-case)
 Large treatment-naïve patient pools  Business friendly environment
 Future markets
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Common History Perceptions
 Most clinical trials were Government  Reduced Cost
funded and supported  Per patient cost
 Since at least 25 years  Data management
 Mostly at govt. hospitals  Trial management
 Mostly on collaborative projects with  Reduced Time
other governments
 Rapid recruitment
 Few Regulations
 All indications
 Private-funded research mostly started  Friendly Regulatory Environment
in the last 10 years, at most.
 Easier approval
 Mostly multi-national corporations
 Faster than US/EU
 Mostly large multi-national CROs
 Less restrictive than US/EU
 Indigenous CROs with limited experience
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Huge Untapped Potential Definite Need for a Recruitment
 Technical
Strategy
 Physicians and hospitals/clinics  Based on indication and population
 Ph.D.s, pharmacists, nurses, etc
 Training resources
 Time of initiation of trial
 Resources  Plan for regulatory, ethics, GCP and
 People quality issues
 Financial  Components of strategy
 For larger trials
 Rapid recruitment  No and location of sites
 Language & Culture  Personnel requirements
 Language is an issue in most regions  Advertisements and promotions
 Huge US influence  Measures to ensure non-coercive activities
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3. Recruitment Plan Framework for Message
 Be honest
 Who is going to recruit, and who are you  What you are doing is research
looking for?  It is experimental or investigational
 What is your message?  There are unknowns
 There may be risks
 What are your barriers?  There may or may not be benefits
 When to initiate recruiting?  Be clear
 Where do you recruit?  Be creative and engaging
 How do you recruit?  Clarify scientific jargon
 Evaluate your recruitment efforts  Make analogies
 Assure confidentiality
 Answer questions
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Training and Quality Management Training and Quality Issues
 General Issues
 Written plans with version control  GCP Compliance
 Collection of feed-back and  Ethics: Approvals by valid of IRB/IECs
documentation of changes  Approval from regulatory agencies
 Setting goals and time-lines  SOPs and Training Issues
 Getting regulatory, ethical and financial  Documentation
approvals before implementing  Compliance issues
 Adaptive recruitment  Coercive actions
 Unapproved processes
 Undocumented processes
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Customized Recruitment Strategies Role of Public Relations
One of the most important component!
All our knowledge is the offspring of our
 Build a comprehensive recruitment plan
perceptions – Leonardo Da Vinci
 Site qualification
 Investigator qualification  Role of media in emerging regions
 Advertisement and promotion of trial  Very vocal, less knowledgeable
 Recruitment camps  Short attention span
 Incentives: Site personnel and patients  Long-term influence
 Within reason and approved by IRB/IEC
 Get plans approved by all applicable IRB/IEC
 Public perception of foreign sponsor
 Deep pockets
 Execution of plan
 Training, initiation, communication and follow-up  Extended reach
 Trouble-shooting  Higher demands for quality and compliance
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4. Future Prospects
 Strong competition among different
countries Thank You!
 Increased use of English as primary Questions and Comments
professional language
 Higher patient awareness Mukesh Kumar, PhD, RAC
 Increased cost Senior Director, Regulatory Affairs
Amarex Clinical Research
 Increased feasibility
Germantown, MD 20874, USA
 Increased supervision by local regulators Tel: 001-240-452-6835
and the FDA Email: mukeshk@amarexcro.com
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