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Patient Recruitment In Emerging Regions July 2010

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

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Patient Recruitment In Emerging Regions July 2010

  1. 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 www.amarexcro.com 3 www.amarexcro.com 4 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 www.amarexcro.com 5 www.amarexcro.com 6
  2. 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 www.amarexcro.com 7 www.amarexcro.com 8 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 www.amarexcro.com 9 www.amarexcro.com 10 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 www.amarexcro.com 11 www.amarexcro.com 12
  3. 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 www.amarexcro.com 13 www.amarexcro.com 14 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 www.amarexcro.com 15 www.amarexcro.com 16 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 www.amarexcro.com 17 www.amarexcro.com 18
  4. 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 www.amarexcro.com 19