Dia feb 2010 final presentation webinar 2 mll
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  • 1. Expanding Clinical Research Beyond Borders:
    The Importance of Latin America
    Dr. Marlene Llopiz
    Venn Life Sciences
    Mexico
  • 2. Growing markets
    Introduce Latin America (LATAM)
    Describe what Latin America has to offer
    What is available in LATAM?
    What about quality?
    What about timelines?
    Assess the possibility of conducting global trials in LA
    Analyze the overall challenges for Latin American countries
    Aims and Objectives
    2
    www.diahome.org
    Drug Information Association
  • 3. Latin America (LA)
    Drug Information Association
    www.diahome.org
    3
    Regions:
    Clinicalresearchin:
  • Growing Markets Playing an Increasingly Important Role
    Drug Information Association
    www.diahome.org
    4
    Average Relative Annual Growth Rate of Clinical Trials in Major Regions
    Growth Rate
    Source: Thiers et al., Nature Reviews Drug Discovery, January 2008
  • 16. In recent years, several regions around the world have provided new frontiers for conducting phase I-IV clinical trials.
    Latin America has come into the limelight for pharmaceutical studies.
    Introduction: The Importance of LA
    5
  • 17. As a vastly populated and varied region, LA provides:
    • large drug naïve patient populations with common and special disease profiles,
    • 18. rapid compliant patient recruitment,
    • 19. motivated and experienced investigators,
    • 20. USA and EC-equivalent medical standards, as well as
    • 21. highly experienced monitoring and project management teams thoroughly trained on GCP and ICH guidelines.
    What is available in LA?
    6
  • 22. What does LA have to Offer?
    Drug Information Association
    www.diahome.org
    7
    Latin America provides:
    • an excellent geographical location
    • 23. a diverse population of over 560 million inhabitants with massive patient populations in all therapeutic indications
    • 24. a ready and professional supply of research facilities and
    • 25. contract research organizations offering professional services for partnering solutions in clinical trial conduction.
  • What about quality?
    Drug Information Association
    www.diahome.org
    8
    Healthcare systems in LA have changed substantially throughout the last years.
    Research has become more proficient with improved standards of operation.
    Regulations have become stricter and formal in line with foreign regulatory and health authorities.
  • 26. Therapeutic Indications
    Drug Information Association
    www.diahome.org
    9
  • Disease Demographics – Latin America
    Leading causes of death:
    Heart disease
    Cancer
    Infectious diseases
    Diabetes
    Mortality rates from infectious diseases are declining
    Incidence of cancer and chronic and lifestyle diseases, heart disease, stroke and diabetes rising; type 2 diabetes increasing dramatically
    Prevalence of diabetes in Mexico is among the world’s highest at 10.6% of adults
    International Diabetes Federation estimates there are 6.9 million people in Brazil and 6.1 million people in Mexico with diabetes
    Drug Information Association
    www.diahome.org
    10
  • 43. Careful selection is made of each Latin American country to participate in global trials dependent on the shortness and complexity or lack thereof of complications for study conduction and of course, patients, sites and investigator availability.
    Country Selection
    Drug Information Association
    www.diahome.org
    11
  • 44. Principal investigators and sites are adequately selected meeting and complying with protocol and study needs and requirements with the necessary experience.
    Site and PI Selection
    Drug Information Association
    www.diahome.org
    12
  • 45. Non-disclosure agreements signed
    Reception of protocols (or synopsis) and request for proposal from clients (at a local or corporate level) are received
    Protocols (or protocol synopsis) are reviewed
    Therapeutic indication is carefully analyzed (incidence and prevalence of the disease in each country)
    Proposals with budgets are submitted dependent on country, sites, patients, complexity of trial, etc.
    Steps to be Taken for Clinical Trials in LA
    Drug Information Association
    www.diahome.org
    13
  • 46. Confidentiality agreements are signed with investigators and site facilities that are pre-selected dependent on client indication
    Feasibility studies are conducted or recommended sites and investigators reviewed (based on protocol purpose, therapeutic indication, patient recruitment, etc.)
    Once sites are selected, all documents are translated into Spanish (and Portuguese for Brazil).
    Powers of Attorney must be obtained for the CRO to manage the trial.
    Steps to be Taken for Clinical Trials in LA
    Drug Information Association
    www.diahome.org
    14
  • 47. A description letter of the study is submitted to the Ethics Committee (EC) together with:
    the protocol,
    informed consent form,
    investigator´s brochure,
    patient diaries and
    CRF´s
    (Documents submitted in the language of submission (Spanish) in addition to English)
    Each site will have a fee that must be paid.
    Steps to be Taken
    Drug Information Association
    www.diahome.org
    15
  • 48. Once approval from EC is obtained and a letter of authorization is obtained, Ministry of Health (MoH) submission must be officially made submitting all study and site documents in English and Spanish.
    In certain countries, after approval from a local EC is obtained, then documents must be submitted to a national EC
    Once MoH approval is obtained, an import license must be solicited providing the manufacturer´s and supplier´s name and address and a description of the product and quantity.
    At each institution, a fee will have to be paid for each procedure.
    Steps to be Taken
    Drug Information Association
    www.diahome.org
    16
  • 49. Certified warehouses are contracted for study supply receipt and distribution to sites.
    In sum, regulatory submission and approvals vary per country.
    Regulatory Timelines
    Drug Information Association
    www.diahome.org
    17
  • 50. Drug Information Association
    www.diahome.org
    18
    Regulatory TimelinesLATAM Country Comparison
    Drug Information Association
    www.diahome.org
    18
  • 51. Recommended Label Requirements
    In Spanish
    Protocol reference number/title
    Contents
    Administration route
    Lot/reference number
    Expiration date
    Storage conditions
    For Investigational Use Only
    Keep out of reach of children
    Manufacturer or Sponsor´s name and address.
    Drug Information Association
    www.diahome.org
    19
  • 52. Import License – after protocol approval
    Timeline: 2-3 weeks
    Rule 4.3: to import samples from an approved protocol (non-controlled drugs and lab kits).
    Exportation: rule 4.3 also allows to export human tissue or serum samples.
    Import/Export Process
    Drug Information Association
    www.diahome.org
    20
  • 53. Serious Adverse Reactions (SARs): 7 days after site´s notification plus 8 days to complete the information.
    Non-serious adverse reactions to be reported at the end of the study.
    Safety letters should be sent every 6 months for phase IV studies.
    For Phase I-III trials, the reports are sent at the end of the study.
    Pharmacovigilance Standard (NOM-220-SSA1-2002)
    Official Communications from CNFV
    Safety Report
    Drug Information Association
    www.diahome.org
    21
  • 54. Clinical Trial Approval in Mexico
    Drug Information Association
    www.diahome.org
    22
    Clinical Trial Approval in Mexico
    Final Protocol (Spanish)
    Investigator’s Drug Brochure (Spanish)
    Informed Consent Form (Spanish)
    Power of Attorney
    Details on importation of CTM, labs
    4-8 weeks
    IRB/EC
    SSA / Secretaria de Salud
    (MOH)
    4 – 6
    weeks
    Clinical Trial Approval Letter
    2 – 3
    weeks
    Import License
    Study Start
  • 55. Challenges with Clinical Research in Latin America
    Drug Information Association
    www.diahome.org
    23
    • Regulatory environment continues to evolve; within the past few years, clinical trials in Brazil and Argentina have experienced long review times.
    • 56. Import/export challenges
    • 57. Competition for investigators and patients as more CROs and pharmaceutical companies conduct trials in the region
    • 58. As in other emerging markets, EDC can be challenging – must ensure that the infrastructure and systems are in place
  • Advantages of Conducting Trials in Latin America
    Drug Information Association
    www.diahome.org
    24
    Large, urban patient population enables faster enrollment and easier patient follow-up
    Population sees clinical trials as a viable healthcare option to gain access to free medication. High patient retention rates.
    More patients per site can be enrolled as compared with North America and Europe
    Well-trained investigators knowledgeable in GCP and ICH guidelines
    High level of investigator involvement in site activities
  • 59. Disease patterns that reflect both the West and the developing world
    Opportunities for time efficiencies with seasonal disease trials
    Region primarily uses just two languages: Portuguese (Brazil) and Spanish
    Quality of data comparable to that of data collected in North America
    Growing pharmaceutical market
    Advantages of Conducting Trials in Latin America
    Drug Information Association
    www.diahome.org
    25
  • 60. One of their main concerns is the timely fashion and quality of regulatory strategies to follow and comply with related to their studies to bring new drugs to market in these parts of the world.
    Timelines
    Drug Information Association
    www.diahome.org
    26
  • 61. Timely submissions and project start-ups are often difficult tasks due to the complexity of the necessary documentation required and delays in their delivery in each Latin American country versus differences with other continents.
    Timelines
    Drug Information Association
    www.diahome.org
    27
  • 62. Placing studies in Latin America provides:
    • pharmaceutical companies and contract research organizations an array of countries for testing drugs,
    • 63. a reduction in costs with strategic multi-centered studies, and
    • 64. credible and objective results for submission to higher regulatory authorities for marketing approvals.
    • 65. International trial results could have significant medical importance and may have an impact on future products.
    Advantages to Studies in LATAM
    Drug Information Association
    www.diahome.org
    28
  • 66. The fact that a given study is approved by FDA / EMEA does not necessarily mean that it will be approved by local MoHs throughout Latin America.
    Avoid as much as possible the need to clarify or submit extra documents to the Ethics Committees and/or MoH after submitting the protocol for review. This significantly delays protocol approval.
    Submit all documents together. Do not submit in bits and pieces.
    Submit the protocol with as many amendments as possible.
    Final Considerations
    Drug Information Association
    www.diahome.org
    29
  • 67. Dr. Marlene Llópiz
    Regional Director for Latin America
    Venn Life Sciences Clinical Research
    +52 55 9171- 0288
    +52 1 55 3335 - 2952
    (Mexico City)
    marlene.llopiz@vlsworldwide.com
    marlene.llopiz@post.harvard.edu
    Contact Information
    Drug Information Association
    www.diahome.org
    30
  • 68. Questions?
    Clinical Trials and Regulatory Affairs in LA
    Drug Information Association
    www.diahome.org
    31