Effective Global Site Budgeting and Cost Management - Holly Squires

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Presentation delivered at "The State of Clinical Development Costs" conference in Philadelphia, PA January 11th and 12th, of 2011.

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Effective Global Site Budgeting and Cost Management - Holly Squires

  1. 1. January 11, 2011, Philadelphia, PA Effective Global Site Budgeting and Cost Management Holly Squires (TTC,llc)
  2. 2. <ul><li>Industry is still the primary source of funding for clinical research </li></ul><ul><li>Close to a third of clinical trial time is spent on recruiting subjects. </li></ul><ul><ul><li>Lead to nearly half of all clinical trials delays </li></ul></ul><ul><ul><li>70% of trials delayed between 1-6 months </li></ul></ul>Current Landscape
  3. 3. <ul><li>Increased scrutiny </li></ul><ul><li>Cost Containment </li></ul>Current Landscape
  4. 4. <ul><li>Currently policy does NOT provide sufficient guidance </li></ul><ul><li>Sponsors must disclose their payment to sites </li></ul>FDA Landscape
  5. 5. <ul><li>Fair Market Value </li></ul><ul><li>Budget Transparency </li></ul><ul><li>Careful Documentation </li></ul>What does that mean?
  6. 6. <ul><li>The financial relationship between clinical investigator-physicians (investigators), who participate in phase 3 clinical trials, and the sponsoring pharmaceutical companies of those clinical trials continues to raise ethical concerns for some. </li></ul>The Issue of Fair Market Value
  7. 7. <ul><li>There is no evidence that the relative amount an investigator is paid influences the subsequent prescribing of the study drug or the prescribing of other drugs from the sponsor company. </li></ul>The Issue of Fair Market Value
  8. 8. <ul><li>Central Budgeting </li></ul><ul><ul><li>i.e. global budgeting is done by a single group, country managers review/approves the budgets </li></ul></ul><ul><li>Decentralized Budgeting </li></ul><ul><ul><li>i.e. country manager are responsible for creating their own budgets </li></ul></ul>Global Budgeting Approach
  9. 9. <ul><li>High level considerations: </li></ul><ul><ul><li>Phase </li></ul></ul><ul><ul><li>Patient population </li></ul></ul><ul><ul><li>Therapeutic area </li></ul></ul><ul><ul><li>Indication </li></ul></ul><ul><ul><li>Visits </li></ul></ul><ul><ul><li>Countries </li></ul></ul><ul><ul><li>Lab type </li></ul></ul>Protocol Review
  10. 10. <ul><li>Procedure costs </li></ul><ul><li>Wages/salaries </li></ul><ul><li>Pharmacy costs </li></ul><ul><li>Patient reimbursement </li></ul><ul><li>Ethics committee fees </li></ul><ul><li>Site costs </li></ul><ul><li>Overhead </li></ul>Basic Components of Investigator Costs
  11. 11. <ul><li>Assumptions </li></ul><ul><li>Line item selections </li></ul><ul><ul><li>Procedures </li></ul></ul><ul><ul><li>Non-procedures </li></ul></ul><ul><li>Cost Selection </li></ul><ul><li>Country Selection </li></ul><ul><li>Study Specific considerations </li></ul>Developing Investigator Grant Budgets
  12. 12. <ul><li>Total grant spending exceeds $8 billion. </li></ul><ul><li>Payment practices and levels vary by country: </li></ul><ul><ul><li>US </li></ul></ul><ul><ul><li>UK </li></ul></ul><ul><ul><li>France </li></ul></ul><ul><ul><li>Italy </li></ul></ul><ul><ul><li>Japan </li></ul></ul><ul><ul><li>Central and eastern Europe. </li></ul></ul>Market Size and Composition
  13. 13. <ul><li>Industry data </li></ul><ul><li>Historic data </li></ul><ul><ul><li>Company data </li></ul></ul><ul><ul><li>Site data </li></ul></ul><ul><li>Study Considerations </li></ul><ul><li>Competition considerations </li></ul><ul><ul><li>Patient pool </li></ul></ul><ul><ul><li>Novelty of compound </li></ul></ul><ul><ul><li>Other similar trials </li></ul></ul>Selecting Costs
  14. 14. <ul><li>Country considerations </li></ul><ul><ul><li>Country specific procedures required </li></ul></ul><ul><ul><li>Overhead differences </li></ul></ul><ul><ul><li>Non-procedure differences </li></ul></ul><ul><ul><li>Rating scales </li></ul></ul><ul><ul><li>National coordinator fees </li></ul></ul><ul><ul><li>Inflation </li></ul></ul><ul><li>Site considerations </li></ul><ul><ul><li>Private vs. public hospital </li></ul></ul><ul><ul><li>KOL </li></ul></ul><ul><ul><li>Previous experience </li></ul></ul>Selecting Costs
  15. 15. <ul><li>Why do some sites receive more; because they can. </li></ul><ul><li>Some empirical variables are associated with how much a site gets relative to others for the same amount of work, e.g., </li></ul><ul><ul><li>Compound novelty, supply and demand, experience, type of site, et. al. </li></ul></ul>Payment and Performance

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