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Acute COPD

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Acute COPD Clinical Trial

Recruitment Challenges:


  • Patients were required to have had 2 documented COPD exacerbations within the previous 12 months for which they received treatment – a high percentage of COPD patients will not seek treatment for an exacerbation if it is not severe enough
  • We had 4.5 months to complete patient enrollment which was not enough time to assume patients would be coming back into the clinic for a routine visit for possible evaluation for clinical trial participation
  • Patients had to produce colored sputum even when they were not having an exacerbation
  • Past medical records were required prior to the screening visit in order to verify previous exacerbations
  • Middle and East Coast regions were hit with a severe winter resulting in an increase of exacerbations during the screening period which caused the patient to have to start the screening process over again.

Solutions:
  • Since the clinical trial was conducted during the end of flu season, we put systems into place at each site to ensure the patients calling with COPD exacerbation symptoms were scheduled for a clinic visit. This provided a greater assurance that patients who may fit the entry criteria were evaluated for possible recruitment into the trial.
  • We created an internal notification mailer for the sites to send to their database of COPD patients alerting them of the trial and the entry criteria. This eliminated the need for someone to do costly chart searches and call potential patients.
  • We created and instituted a robust external patient recruitment program to enhance the sites pool of candidates for screening.

End Result:

The clinical trial was fully enrolled within 1 month of the corporate goal