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Cystic Fibrosis: phase iii

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Cystic Fibrosis: Phase III trial for ages 12 and above

Trial enrolled 282 subjects in 13 months (over-enrolled by 15 subjects) and completed full enrollment 1 month behind schedule

Recruitment challenges:
  • Small percentage of patients to draw from Limited number of centers who treat CF patients and do research Strict limitations of antibiotic use prior to screening Majority of the recruitment period was during the winter months with increased chance of infection and hospitalization 
  • Worked closely with each individual site to ensure all possible subjects were identified and screened Listed the trial on Clinical Trial Spotlight web site and heightened the awareness both locally and nationally to drive subjects for screening Created and implemented a communication program to keep sites connected and enthused about the trial
End Result:

The majority of sites remained very engaged in the trial and continued identifying and screening subjects Trial enrolled 282 subjects in 13 months – 1 month behind schedule but over enrolled by 15 subjects

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