Diese Präsentation wurde erfolgreich gemeldet.
Wir verwenden Ihre LinkedIn Profilangaben und Informationen zu Ihren Aktivitäten, um Anzeigen zu personalisieren und Ihnen relevantere Inhalte anzuzeigen. Sie können Ihre Anzeigeneinstellungen jederzeit ändern.

Patient Recruitment In Emerging Regions July 2010

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

  • Loggen Sie sich ein, um Kommentare anzuzeigen.

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

×