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Industry Sponsored Trials at Academic Medical Centers: Goals and Requirements

Industry Sponsored Trials at Academic Medical Centers: Goals and Requirements. 2 nd Annual Clinical Research Management Workshop Briggs W. Morrison, MD June 22, 2009. Agenda. Criteria for selecting investigative sites How are the CTSA institutions doing? Process improvement opportunities.

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Industry Sponsored Trials at Academic Medical Centers: Goals and Requirements

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  1. Industry Sponsored Trials at Academic Medical Centers: Goals and Requirements 2nd Annual Clinical Research Management Workshop Briggs W. Morrison, MD June 22, 2009

  2. Agenda • Criteria for selecting investigative sites • How are the CTSA institutions doing? • Process improvement opportunities

  3. Selecting investigative sites • Quality • Patient experience • Patients relevant to the protocol hypotheses • Ability to meticulously follow protocol • Data complete, accurate. and interpretable • Speed • Initiating the trial • Enrolling patients • Cost Why would we chose your site over other CTSA sites or non-academic sites?

  4. CTSA Performance: Analysis Methods • Pfizer sponsored trials 2006 – present • Compare CTSA institutions with other Academic Medical Centers and with non-academic research sites • US sites only • Data displayed as median with box (25%-75%).

  5. Quality Metrics • Patient experience • Patients relevant to the protocol hypothesis • Number of patients enrolled • Predictability of enrollment projections • Ability to meticulously follow protocol • Protocol violators • Data complete, accurate, and interpretable • First pass data quality

  6. Can the site enroll even 1 patient? 0.7 0.6 0.5 0.4 Proportion of Performing sites 0.3 0.2 0.1 0 Non AMC CTSA AMC Other AMC ~ 30% of activated sites do not enroll a single patient

  7. Can the site enroll at least 3 patients? ~ 50% of activated sites do not enroll more than 3 patients

  8. 35 30 25 20 Deviation Count 15 10 5 0 CTSA - AMC Non - AMC Other - AMC Count 397 6578 615 Median 4.0 3.5 3.0 Protocol Deviations

  9. 4 3.5 3 2.5 Standardized Score 2 1.5 1 0.5 0 CTSA_AMC Non - AMC Other - AMC Count 383 6475 598 Protocol Deviations (normalized within protocol)

  10. Speed Metrics • Initiating the trial • Final approved protocol (FAP) received at your site until site screens first patient (FSFV) • Final approved protocol received at your site until final contract signed • Enrolling patients • First patient enrolled to last patient enrolled • Predictability of enrollment projections

  11. 700 600 500 400 Calendar Days 300 200 100 0 CTSA - AMC Non - AMC Other - AMC Count 1330 17072 2272 Median 265.5 210.0 257.0 Final Protocol to First Screened Patient

  12. 350 300 250 200 Calendar Days 150 100 50 0 CTSA - AMC Non - AMC Other - AMC Count 301 4059 556 Median 165 42 141 Final Protocol to Contract Signed

  13. 3 2.5 2 Standardized Score 1.5 1 0.5 0 CTSA - AMC Non - AMC Other - AMC Count 300 4059 556 Final Protocol to Contract Signed (normalized)

  14. Median~ 5 – 6 months 3 2.5 2 1.5 Standardized Score 1 0.5 0 - 0.5 - 1 CTSA AMC NON AMC NON CTSA AMC Count 663 9499 1167 Median 1.0 1.1 1.0 Enrollment: first screened patient to last (normalized)

  15. Cost Metrics • Per patient clinical grants costs paid by Sponsor • Actual costs of doing the work at your institution. • Opportunity costs

  16. 30000 27500 25000 22500 20000 17500 Costs US$ 15000 12500 10000 7500 5000 2500 0 CTSA - AMC Non - AMC Other - AMC Count 281 3774 536 Median 9065 7000 8549 Per Patient Costs

  17. Per Patient Costs (normalized within protocol)

  18. How are CTSA institutions doing? • Within the limitations of this analysis, CTSA site performance is generally about the same as that of non-academic centers or other academic centers • Overall a bit slower getting started • Contracting takes longer • There is significant variation between sites even within a given study. • There is significant opportunity to increase speed and decrease opportunity costs.

  19. Process Improvement Approaches • Lean • Positive Deviance

  20. Think Lean • Map all processes in detail • Eliminate non-value added steps • Data useful to determine if value added or not • Eliminate muda, especially “waiting”. Mindset of “relentless and passionate pursuit of perfect process.”

  21. Positive Deviance In every community, organization, or social group, there are individuals (“positive deviants”) whose exceptional behaviors or practices enable them to get better results than their neighbors who have the exact same resources. The solution already exists within this community – it just needs to be discovered by its members.

  22. In closing Set aggressive goals – and beat them! • All patients who participate in clinical trials at your institution will advise their friends and family to participate • Every trial activated at your institution will enroll at least 5 patients. • The time from when you receive the final protocol until you enroll your first patient will never exceed 100 calendar days • The time from when you receive the final protocol until you have an agreed contract and budget will never exceed 30 days. • No trial conducted at your institution will have a protocol violation. • The first pass data quality will approach 100% for all trials conducted at your institution.

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