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Enhancing Clinical Trials Integration: A Success Story

Learn how Mayo Clinic Cancer Center improved clinical trials performance with industry support, achieving significant reductions in timelines and inefficiencies in 2009. Discover key strategies, challenges, and successful outcomes.

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Enhancing Clinical Trials Integration: A Success Story

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  1. ACTION Accelerating Clinical Trials Integration and Overcoming Non-value-add Kelly Paulson Mayo Clinic Cancer Center

  2. Project Introduction • Purpose: Improve performance of key processes associated with conducting clinical trials that are PI initiated with industry support • Goal: 20% reduction; anticipated: 50% reduction • Timeline: January – December, 2009 • Collaborative effort with Cancer Center, IRB, Legal, Budgeting

  3. What Worked Well - Project • Dedicated Project Manager and Quality Improvement Expert • Active involvement from major players (IRB, Legal, physicians, etc.) • Voice of the customer • Ongoing communication • DMAIC process • Metrics

  4. What Worked Well - Project • Dedicated IT resources & website • Recognize what you cannot/should not change • Value stream maps – visual representation • Sharing responsibility/accountability among the 10 teams

  5. Project Teams • Protocol Development • Budgeting • Disease Oriented Groups • Protocol Activation • Case Report Forms • Training • Ancillary Committees • IT • Internal Communications • External Communications (Sponsors)

  6. Value Stream Map

  7. What Worked Well – Changes • Earlier start • Combining activities/forms • Standardize processes • Eliminate duplication/manual processes • Eliminate PI admin responsibilities • Creating templates/training materials/dashboards

  8. Training Pathway

  9. Protocol Management Tool

  10. Challenges • Staying committed to deadlines along with other work obligations • Training • Accountability – sustaining changes • Some processes are out of our control

  11. Questions?

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