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Trial start up slides 14-feb2013


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Trial start up slides 14-feb2013

  1. 1. The  Joys  and  Woes  of    Clinical  Trial  Start-­‐Up:     A  Global  
  2. 2. Introduc;on  
  3. 3. Polling  Ques;on  #1  
  4. 4. Off  to  the  races!  
  5. 5. Some  Start-­‐Up  Sta;s;cs  Data  from:  Tu2’s  Center  for  the  Study  of  Drug  Development’s  “Benchmarking  the  Study  Ini.a.on  Process”  
  6. 6. Polling  Ques;on  #2  
  7. 7. The  Buck  Starts  Here  
  8. 8. Running  the  Heats  
  9. 9. Sizing  up  the  Playing  Field  
  10. 10. Pre-­‐race  Warm-­‐up  ü  Hold  site  accountable  for  feasibility  assessment  responses  ü  2  levels  of  assessment:   –  “Interest/Ability”   –  Detailed  “Assessment”  ü  Follow-­‐up  with  phone  call  ü  CRAs  must  know  the  study     –  What  is  known  about  study?  Are  addi.onal  steps  needed?       –  Are  the  popula.on  and/or  enrollment  numbers  listed  in  their  Feasibility   accurate?  ü  Schedule  .me  to  meet  w/Budget  and  Contracts  contacts  
  11. 11. Entrance  Fee  and  Applica;on  
  12. 12. The  Winning  Formula  
  13. 13. Targe;ng  the  Finish  Line  
  14. 14. Ques;ons?