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Highlights from ExL Pharma's 4th Latin America Clinical Trials

  1. 1. Highlights from ExLPharma’s 4th Latin America Clinical Trials <br />February 25-26, 2010<br />Miami, Florida<br />
  2. 2. University/Industry Collaborations<br />
  3. 3. US Research Institutions and Industry<br />Rhetoric<br />Political<br />Experts<br />History<br />Triple Helix and the Entrepreneurial University<br />Shared Goals and Complementary Strengths<br />
  4. 4. IRB Collaboration and Enhancement<br />Human Subjects Research Enhancement Program<br />Sponsored by National Institutes of Health<br />John E. Fogarty International Center<br />12 months, $50,000<br />Objectives<br />Develop sustainable electronic systems, procedures and communication methods<br />Increase administrative, scientific, socio-cultural and ethical competencies of IRB members through joint workshops, short-term exchange and training activities<br />Create sustainable research ethics training courses for global health researchers<br />
  5. 5. IRB Collaboration and Enhancement<br />Projects<br />Specific needs determined in partnership with developing country ethics review committee<br />IRB training, investigator training, best practices, systems<br />Benefits of Participation<br />Improve Ethical Review Committee competencies<br />Address critical barriers in review<br />Reduce review time<br />Increase Investigator knowledge of research integrity requirements<br />Improved protocols require less time to review and approve<br />Develop knowledge leaders in research integrity<br />
  6. 6. Three Unlikely Collaborators<br />
  7. 7. EDICT<br />The Eliminating Disparities in Clinical Trials Project<br />2005-2009<br />Clinical Trials Navigation<br />Community Health Worker/Promotora<br />Promotora de Salud<br />Health promoter<br />Bridge between communities and external systems<br />Social and cultural knowledge<br />Proven model<br />Training and certification<br />
  8. 8. Microfinance Industry<br />Purpose<br />Give poor people access to credit, ultimately alleviating poverty<br />Types of MFIs<br />Commercial banks<br />Microfinance banks<br />Microfinance NGOs<br />Regulated and unregulated<br />Types of Lenders<br />Groups<br />Individuals<br />
  9. 9. Clinical Trial Recruitment and Retention Utilizing Promotoras Within MFI Infrastructure<br />Trust Group<br /><ul><li> Neighborhood level
  10. 10. Weekly meetings
  11. 11. Business training and support
  12. 12. Health education
  13. 13. Preventative health services</li></ul>Promotora<br /><ul><li> Clinical Trial Education
  14. 14. Clinical Trial Recruitment
  15. 15. Clinical Trial Retention
  16. 16. Phase IV
  17. 17. Post Trial Management</li></li></ul><li>Geographical Focus<br /><ul><li> Oversaturation of Microfinance
  18. 18. Nearing Saturation
  19. 19. Strong Microfinance Presence, Medium Market Reach
  20. 20. Low Microfinance Presence, Huge Potential Market
  21. 21. Growing Microfinance Presence, Huge Potential Market</li></li></ul><li>Benefits and Obstacles<br />Benefits<br />Microfinance is an expanding industry with an existing infrastructure<br />CHW/Promotora model<br />Contributes to sustainability of community by job creation leading to economic self-sufficiency<br />Increased access to community improves participant recruitment<br />Follow-through enhances participant retention<br />
  22. 22. Benefits and Obstacles<br />Obstacles<br />Communities of devastating poverty<br />Unreliable social infrastructure<br />Raises Significant Ethical questions<br />Vulnerable population<br />Ability to comprehend consent<br />Subject to undue influence or coercion?<br />Weak ethical oversight<br />
  23. 23. Quality in Clinical Research<br />
  24. 24. Quality In Trials <br /><ul><li>The integrity of all trial’s data is dependent on high quality, GCP/ICH compliant execution of trials at all sites and in all countries</li></li></ul><li>Poor Quality Cost<br />Correct More Faults Earlier!<br />QA/QC Late in the Project $<br />QA/QC Early in the Project $<br />Not Here!<br />Cost to Correct<br />Find Here<br />
  25. 25. Continuing Improvement toward Operational Excellence<br />Client<br />Client<br />Client<br />Local Management<br />Analyzing, objectives, indicators<br />Measurement<br />Improvement<br />4QY<br />4QNY<br />Satisfaction<br />Satisfaction<br />Output<br />Input<br />Product<br /> processing<br />Needs<br />MYR<br />Quality Management Team <br />Activities that add value<br />Information workflow<br />16 | 4th Latin America Clinical Trials Congress| US – Miami 25 -26 Feb 10 | Quality in Clinical Research | B. Funes | Business Use Only <br />
  26. 26. QualityOversight<br />Quality Assurance (QA) is fault prevention through process design and auditing and ensuring appropriate control steps are followed<br />-Creating processes, procedures, tools, etc. to prevent faults from occurring<br />-Examples: Templates, checklists, guides, SOPs<br />Quality Control (QC) is fault/failure detection through static and/or routine testing<br /> -Examining against pre-determined standards and criteria to measure conformance<br />-Examples: Periodic Self Assessments, Quality Plan, peer reviews, business walkthrough <br />
  27. 27. Whatis a Quality Plan<br />Define your Quality Goals (Process & Metrics)<br />Selects appropriate detection and prevention methods<br />Analyze and be realistic about where defects come from (Root/Cause)<br />Establish a formal in-process and inter-process review & checks<br />Establish a Training (Lessons Learned, sharing Best Practices, Quality Management mindset and change culture)<br />Establish a Failure mode analysis (frequency of errors, criticality)<br />Determine Costs of failure, rework, repair, waste, complaint resolution, product return and replacement<br />Establish a Help line support<br />
  28. 28. Supervision of the Conduct of Clinical Investigation <br />What is Appropriate Delegation of Study related Tasks?<br />What is adequate Training?<br />What is adequate Supervision of the Conduct of an Ongoing Clinical Trial?<br />What are an Investigator’s Responsibilities for Oversightof Other Parties involved in the Conduct of a Clinical Trial?<br />
  29. 29. Protecting the Rights, Safety, and Welfare of Study Subject<br />Reasonable Medical Care Needed by Participation in a Clinical Trial<br />Reasonable Access to Medical Care<br />Protocol Violations that Present Unreasonable Risks<br />
  30. 30. Function of essential documents<br />Demonstrate:<br /><ul><li> compliance of the investigator, sponsor and monitor
  31. 31. Standards of GCPs
  32. 32. all applicable regulatory requirements</li></li></ul><li>Good Documentation Practices<br />ALCOA rule<br />A:Accurate: The document must be error free.<br />L:Legible: The document must be readable by internal/external customers<br />C:Concise: The document must tell the entire story and be understood by internal/external customers. Contemporaneous<br />O: Organized: follows an standardized practice, easy to access and follow the story. Original<br />A: Attributable: Each aspect of the document must be traceable, such as, who recorded it, where and why.<br />
  33. 33. Outsourcing in Clinical Research<br />
  34. 34. Outsourcing in Clinical Research<br />R&D – Importance<br />For Country<br />New treatments, new concepts, improve life expectancy, investments, drive scientific development growth, technological development<br />For Patients <br />Access to high technology and treatment, improve survival, improve quality of life<br />For Professionals<br />Scientific development, right use of drugs, international exposure <br />For Sponsors <br />Add and create value to the companies, drive the business growth, introduce new drugs and concepts, adequate life cycle management of products<br />
  35. 35. Outsourcing in Clinical Research<br />R&D – Importance x Implications<br /><ul><li> R&D drive business growth
  36. 36. R&D costs have increased and the new products approved reduced
  37. 37. Drug efficiency has declined
  38. 38. Increase R&D productivity reducing development times and costs
  39. 39. Succesful implementation of projects and high performance in R&D is essential</li></li></ul><li>Outsourcing in Clinical Research<br />R&D – Performance<br /><ul><li> Strategic Alliances and Partnerships
  40. 40. Mergers and Acquisitions
  41. 41. In-licensing
  42. 42. Strong Scientific Rational and Study Design
  43. 43. Succesful implementation of CTs ( Expertise )
  44. 44. Metrics, KPIs
  45. 45. Working Model</li></li></ul><li>Outsourcing in Clinical Research<br />R&D – Outsourcing - Objectives <br /><ul><li>Strategy to conduct multiple projects at same time
  46. 46. Share risks and flexibility for new conditions and needs
  47. 47. Reduce Operating costs
  48. 48. Focus in what is important (Business and Trials)
  49. 49. Improve Quality of Services
  50. 50. Access to expertise and tecnology
  51. 51. Resources available for other purposes
  52. 52. Reduce Headcount</li></ul>Source: IIR Clinical Develpment Outsourcing 101 Oct,2006 Debbie Kerr-Leathem and Bob Assenzo,, Sep,2007<br />
  53. 53. Outsourcing in Clinical Research<br />R&D – Outsourcing or not <br /><ul><li> Clear Objective and Time lines
  54. 54. Expertise needed
  55. 55. Evaluate capabilities
  56. 56. Resources needed and Weaknesses
  57. 57. Cost/Benefit</li></li></ul><li>Outsourcing in Clinical Research<br />R&D – Types of Outsourcing <br />Full Service<br /><ul><li> One vendor for all services
  58. 58. Increased efficiency, better communication
  59. 59. Vendor could not be good in all services</li></ul>Source: IIR Clinical Develpment Outsourcing 101 Oct,2006 Debbie Kerr-Leathem<br />
  60. 60. Outsourcing in Clinical Research<br />R&D – Types of Outsourcing <br />Functional<br /><ul><li> Different Vendors for different services
  61. 61. Dedicated resources, best performance, optimize expertise
  62. 62. Complex communication</li></ul>Source: IIR Clinical Develpment Outsourcing 101 Oct,2006 Debbie Kerr-Leathem<br />
  63. 63. Outsourcing in Clinical Research<br />R&D – Types of Outsourcing <br />Project Specific x Program<br /><ul><li> Specific vendor for a project or for one drug development
  64. 64. Expertise, save time, better communication, efficiency
  65. 65. Full program in charge of one vendor </li></ul>Source: IIR Clinical Develpment Outsourcing 101 Oct,2006 Debbie Kerr-Leathem<br />
  66. 66. Outsourcing in Clinical Research<br />R&D and Outsourcing Principles <br /><ul><li>Define clear objectives
  67. 67. Establish clear metrics
  68. 68. Determine KPIs to be evaluated periodically
  69. 69. Share processes and SOPs
  70. 70. Clear and free communication
  71. 71. Expectations and needs well understood
  72. 72. Commitment
  73. 73. Team work culture
  74. 74. Regular reports</li></li></ul><li>Still have any questions? For additional information on ExLPharma’sLatin America Clinical Trials, please visit<br />

Editor's Notes

  • For this grant application, the focus is really creating a partnership between 2 ethical review committees, one in a developing country and one at a US institution. The reasoning behind this is twofold:Bureaucratic – the funding comes from ARRA and in order to use them as a funding source, the focus of the grant must be to accelerate the speed of research through IRB collaboration.Limited Funds – This is viewed as a pilot project to develop relationships between IRBs which can be built upon in the future and used for larger grant opportunities.Although the justification for this funding opportunity comes from the Federal requirement that NIH supported investigators must obtain ethical approval at both the US and foreign institutions, any improvements in the ethical review process will benefit all research sponsors.
  • Developing country as defined by World Bank (according to Gross National Income per capita as “low income” “lower middle income” and “upper middle income”
  • Launched in 2005, the EDICT Project was developed to design practical and realizable policy solutions to disparities in clinical trial participation. The community health worker or promotora model is used becausepromotoras are effective communicators and may act as the bridge between external systems and the community they serve. They may act as change agents within their naturally occurring social networks. Serving as a bridge promotoras are able to break through barriers to participation in clinical trials based upon our experience in the US. For examples, many populations do not turn to health care professionals for health information but seek out authority figures in their own social network. This also contributes to the lack of knowledge of the existence of clinical trials within the community.Promotora services are delivered for the most part through home visits and group presentations. Promotoras go where people congregate; health fairs, church, neighborhood meetings, factories gas stations, grocery stores.This model has been used successfully for decades as an approach to reducing disparities in health status and health care access in the US.Many states in the US have certification programs and the CHW/Promotora is recognized job classification by the US Dept. of Labor.
  • The Microfinance Industry became active in Latin America in the 1990s and even more so in the early 2000sThe MFI industry includes small short-term loans, insurance, banking products, Microcredit in the true sense of the term, always enables the borrower to create wealth.
  • Each Loan Officer has approximately 10-20 Trust Groups they work with or on average about 200 clients at one time.Within the Trust Group is where the action is. Basic business education plus health education, discussion on social and public health issues as well.For many MFIs, the majority of staff is native to the local community in which they work.Investment It varies from country to country but between 60-80% of all clients are women.
  • Typically, MFIs operate in places where it is difficult to conduct research.Geographically isolatedPolitically unstableTechnologically backwardEducationally disadvantagedHowever, MFIs working in these countries focus on teaching entrepreneurs the following topics:Cash flow (control, management); financial literacy (budgeting, profit); value chain (suppliers, customers)So if they are able to understand these topics, then they should be able to comprehend issues such as experimental, consent, etc..
  • Deviation in just a few centers can invalidate/change the results of an entire trial (as patient data is excluded), jeopardizing submissions (or even existing approvals if issues are found very late)Such events potentially have widespread reputational and credibility impact in the public domain Even in cases where problems are discovered relatively early, the resource and time spent in remediation far out-weighs that which would be expended in “getting it right the first time”
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