The  Joys  and  Woes  of    Clinical  Trial  Start-­‐Up:    

A  Global  Perspec.ve  

Introduc;on  

Polling  Ques;on  #1  

Off  to  the  races!  

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”  

Polling  Ques;on  #2  

The  Buck  Starts  Here  

Running  the  Heats  

Sizing  up  the  Playing  Field  

ü  Hold  site  accountable  for  feasibility  assessment  responses  ü  2  levels  of  assessment:  

–  Ini.al  “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  

Pre-­‐race  Warm-­‐up  

Entrance  Fee  and  Applica;on  

The  Winning  Formula  

Targe;ng  the  Finish  Line  

Ques;ons?