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OCT 2016 KJA Slides _FINAL


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OCT 2016 KJA Slides _FINAL

  1. 1. Case study: Risk and contingency management in clinical trials Kevin J. Anderson, MBA Associate Director, Clinical Operations
  2. 2. 2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Alexion Pharmaceuticals, Inc. (“Alexion”) or Quintiles Transnational, Inc. (“Quintiles”) or their directors, officers, employees, volunteers, members, chapters, councils, communities or affiliates, or any organization with which the presenter is employed or affiliated.
  3. 3. 3 Agenda  Risk and contingency management on one program within the Alexion-Quintiles partnership, including short term mitigation and long term contingency planning for:  Slow site selection  Slow start up execution  Slow patient enrollment  Lack of site and patient centricity in study execution
  4. 4. 4 Background • 2 POC studies in the rare and ultra rare disease space • Team had small budget, few sites • Everything was far behind original projections • Needed to mitigate current issues and map out a risk management plan for future studies • Team did and results were significant • The lessons we learned can be applied broadly
  5. 5. 5 Systematic Process Examination • Could Not Change • Could Change • Not Working • Working Site Selection Site start Up Site & Patient Centricity Patient Recruit.
  6. 6. 6 Site Selection • Challenge our site numbers • Reach out internally across therapeutic areas • Global feasibility • Search Engine Optimization (SEO) and social media • Patient Advocacy groups • Medical Informatics • Clinical Trial Educator (CTE)
  7. 7. 7 Site Start Up– Regulatory & ECs Tier Sites Reg. Kick Off Daily Calls Joint Folders You’re Off! Early “Go”
  8. 8. 8 Site Start Up-Contracts Start with medium budget Country list to Legal/Contracts early At country “go” both groups start on contracts Weekly Prioritization Calls
  9. 9. 9 Patient recruitment F2F visits Social Media Plan Mobile DLs Study Apps SEO Plan CTE • Educate staff on recruitment techniques • Network wit HCPs • Offer creative solutions
  10. 10. 10 Site centricity • Monthly PI calls • Monthly SC calls • Add staff • Approve budget increases • Apps and/or web portals • Pay for pre-screening
  11. 11. 11 Patient Centricity Patient centric organizations Telemedicine Social Media Sharing data with patients Home Infusions Wearable devices
  12. 12. 12 Results From .36 patients per month To 2.5 patients per month Chronic Study From 1.25 pts/mo. To 2.0 pts/mo. Acute Study From bottom 25% To top 5% SSV to SIV
  13. 13. 13 Conclusions • Risk & Contingency Management plans are critical • Should have in place before studies start • Perform ongoing reviews-should be living documents • Quarterly F2F meetings with CRO are recommended • If these occur, positive improvements on current and future studies are highly likely