Clinical Trials and Innovation in the Health sector Accelerating access for patients to best medicin

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Clinical Trials and Innovation in the Health
sectorAccelerating access for patients to best
medicine The system, the challenge

• Monique Bégin
• Judy Erola
• George Wells
• André Potworowski
• Building excellence in clinical research and
  clinical trials
• Ottawa, February 10 11, 2005,

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Context

• Average drug development cost in the 1990s is
  802 M (US)
• Of this, 465 million are clinical costs
• Fastest rising component, 4 fold increase in a
  decade
• Tufts Centre for the Study of Drug Development
  2003

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The Study

• Feasibility Study
• Stakeholders roles,contributions, interactions
• Best practices innovation efficiency
• Scope clinical research, testing regulations
  of new drugs
• End objective Access by patients to new medicine

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The system

• Innovation system -- An integrated perspective
• At least 13 major stakeholders/players
• Patients at the core
• Little quantitative data
• Powerful framework for AQRC

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The Clinical Trials System in Canada Key Players
and Institutions
Site Management Orgs.
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The system (contd)

• 800 million - 1 billion
• Many regulatory regimes (fed-prov, etc)
• International competition
• On balance, beneficial to Canada
• Patients want more Clinical Trials and better
  access to them

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The Challenge (1)

• Absence of reliable metrics and data
• Research, explore, review, fill in gaps
• PATIENTS
• Increased involvement, transparency
• Easier access to CTs
• Faster, easier access to new drugs

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The Challenge (2)

• Health Canada drug approval system
• Optimal model for organization
• Flexibility in funding
• Meet challenges of new technology
• Appropriate structure, organization, reporting
  and accountability
• Balance cost recovery and stewardship role
• Best practices from other countries
• Canadian leadership role internationally

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The Challenge (3)

• Research Ethics Boards
• Increase coordination
• Provide uniform standards and accreditation
• Ensure proper training and resourcing.
• Provincial Formularies
• Accelerate harmonization
• Ongoing process of bringing new medicines to
  Canadians equitably

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The Challenge (4)

• Allied Health Professionals
• HR Strategy
• Investigators
• Improve trust, collaboration
• CIHR
• Enhanced Role
• Hospitals and Faculties
• Increase capacity infrastructure, remove
  barriers

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The Challenge (5)

• Industry Large Pharma
• Greater openness and transparency with academic
  research community
• Industry Biotech
• Different needs for various stages capital
  financing, other skills and resources

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The Challenge (6)

• Clinical Research Organizations
• Industry analysis
• Private Research Clinics
• Growth, distribution and scope, links to health
  research knowledge translation
• Private REBs, scope, practices
• Site Management Organization
• Benchmark models, best practices

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The Challenge (7)

• Canadas competitive position
• Become a bigger player in the field of clinical
  trials.
• Identify market niches
• Build up Canadian clinical trial capacity, and
  attract more private sector investment
• Public Health, Safety, Innovation

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Progress since study

• Presentation to Standing Committee of House of
  Commons on Health
• Five workshops in Ottawa, Montreal and Toronto
• CIHR new initiative on clinical research

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Key issues

• Demonstrate the benefits of Clinical Trials and
  Clinical Research
• Link to broader picture and political agendas of
  public health, innovation and commercialization
• Make a business case for a national strategy on
  clinical research to increase investment, say,
  tenfold (x10)

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Questions for Discussion

• Today
• Risks and benefits of clinical trials Do we want
  more clinical trials in the region,
  industry-sponsored or led vs. peer- reviewed or
  investigator-sponsored, and what should be the
  balance?
• What are the most important/time consuming steps
  and obstacles to carrying out more and better
  clinical research at the regional level
• Tomorrow
• What are some of the best practices that we can
  learn from others in Canada or in other
  countries, which could improve innovation and
  clinical trials in this region?