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Observational Studies: Strategic, Operational and Budgetary Considerations

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Observational Studies: Strategic, Operational and Budgetary Considerations - Trotter_1-11-2012

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Observational Studies: Strategic, Operational and Budgetary Considerations

  1. 1. Observational Studies: Strategic, Operational and Budgetary Considerations 11 January 2011 Jeff Trotter – Executive Vice President – Phase IV Development
  2. 2. Post-approval research today – Safety and value <ul><li>Requirement </li></ul><ul><ul><li>In some countries, ‘real world’ post-approval experience data must be submitted to maintain market approval. </li></ul></ul><ul><ul><li>Increasingly, some form of safety surveillance / risk management program will be mandated and enforced. </li></ul></ul><ul><li>Responsibility </li></ul><ul><ul><li>Corporate accountability for post-approval safety is increasingly expected by various constituencies. </li></ul></ul><ul><ul><li>Documentation of clinical / economic / humanistic value is critical for commercial acceptance and accelerated product uptake. </li></ul></ul><ul><li>Opportunity </li></ul><ul><ul><li>If managed proactively, safety surveillance obligation can be controlled. </li></ul></ul><ul><ul><li>An observational study can be a cost-effective, high ROI mechanism for fulfilling the post-approval obligation for both safety and effectiveness data. </li></ul></ul>
  3. 3. Real world perspectives Real world research “ The conditions under which products are examined for regulatory approval are generally not the conditions under which they are actually used…”
  4. 4. <ul><li>… RCTs can be too artificial in intent and design, and therefore poorly reflective of actual medical practice </li></ul><ul><ul><li>Tight inclusion criteria </li></ul></ul><ul><ul><li>Experimental protocol </li></ul></ul><ul><ul><li>Tight procedural control </li></ul></ul><ul><ul><li>Randomization, blinding, placebo, etc. </li></ul></ul><ul><ul><li>Short in duration </li></ul></ul><ul><ul><li>Homogeneous sites </li></ul></ul><ul><li>We need to know how a product is used and how it “performs” under real world conditions </li></ul><ul><ul><li>Safety </li></ul></ul><ul><ul><li>Clinical outcomes (CER) </li></ul></ul><ul><ul><li>Economic value </li></ul></ul><ul><ul><li>Humanistic value </li></ul></ul>Real world (observational) studies are needed, because…
  5. 5. Different conditions require different processes
  6. 6. Operational Issues and Challenges <ul><li>Site selection </li></ul><ul><li>Site training and start-up </li></ul><ul><li>Site “interaction” ( monitoring ) and management </li></ul><ul><ul><li>Site motivation </li></ul></ul><ul><ul><li>Protocol “adherence” </li></ul></ul><ul><ul><ul><li>Inclusion </li></ul></ul></ul><ul><ul><ul><li>Procedures </li></ul></ul></ul><ul><li>Data management </li></ul><ul><ul><li>Accommodating multiple measures </li></ul></ul><ul><ul><li>EDC issues </li></ul></ul><ul><ul><li>Data quality </li></ul></ul><ul><ul><ul><li>SDV </li></ul></ul></ul><ul><li>Analysis </li></ul><ul><ul><li>Biases, etc. </li></ul></ul><ul><ul><li>Findings </li></ul></ul><ul><ul><li>Reporting (communications </li></ul></ul>
  7. 7. Observational Studies are a “different animal” <ul><li>So, who “owns” it…? </li></ul><ul><li>HEOR </li></ul><ul><li>Epidemiology </li></ul><ul><li>Medical Affairs </li></ul><ul><li>Marketing / Product Management </li></ul><ul><li>Clinical Operations </li></ul><ul><li>Development </li></ul><ul><li>Safety / PV </li></ul>
  8. 8. CRO Proposal Product Management, HEOR Clin Ops RFP/Bid Grid Outsourcing
  9. 9. Highlights from survey on Observational Research <ul><li>Motivation: “Schizophrenic” RFPs </li></ul><ul><ul><li>i.e., uncertainty, inconsistency, imprecision, over-engineering, etc. </li></ul></ul><ul><li>Many functional areas have some involvement in observational research studies </li></ul><ul><li>Many different purposes underlie these studies </li></ul><ul><li>“ Observational research” goes by many names </li></ul><ul><li>Sponsors have varying levels of “comfort” with observational research </li></ul><ul><li>Most sponsors do not have defined processes for observational studies </li></ul><ul><ul><li>Design, Procurement, Operational, Analytical, etc. </li></ul></ul><ul><li>Sponsors have varying expectations for the “conclusiveness” of findings from observational studies </li></ul><ul><li>Sponsors are concerned that regulatory/health authorities “don’t get it” </li></ul><ul><li>Sponsors plan to become increasingly involved in observational research </li></ul>
  10. 10. Observational Research: Budgetary Implications <ul><li>Observational Research is a different animal </li></ul><ul><ul><li>Strategic objectives </li></ul></ul><ul><ul><li>Activities, resources, units </li></ul></ul><ul><ul><li>Process </li></ul></ul><ul><li>Applying “traditional” processes to an Observational Study leads to… </li></ul><ul><ul><li>Over-engineered, overly expensive study </li></ul></ul><ul><ul><li>Study not properly designed </li></ul></ul><ul><ul><li>Project not undertaken </li></ul></ul><ul><li>Need for clarity and flexibility </li></ul><ul><ul><li>Observational Research may be outside traditional comfort zones </li></ul></ul><ul><ul><li>Specialized skills are required </li></ul></ul><ul><li>Observational Studies can be very cost-efficient </li></ul><ul><ul><li>Balance objectives, analytical granularity, data management, etc. </li></ul></ul>

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