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Pseudobulbar Affect: phase iii

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Pseudobulbar Affect (Central Nervous System): Phase III

 Recruitment Challenges:

  • Sites had lost interest in the clinical trial
  • Trial was averaging 5 enrolled patients per month with over 60 open centers
  • Mass media was done but was not appropriate for recruiting this particular patient population 
  • Patient retention for the clinical trial was lacking 

  • RESolutions analyzed what patient recruitment efforts had been done to date and the results obtained
  • Determined that this patient population would need to be educated about the clinical trial and referred for participation from a source that they trusted
  • Created a very patient-specific outreach program targeting areas the patients and their loved ones already trusted and were going to for their medical information which included both physicians and non-profit organizations
  • Established relationships with these various groups to help promote education about the clinical trial in their local area
  • Worked very closely with the trial sites to help facilitate patient referrals both internal and external
  • Resulted in successfully enrolling 312 patients in 14 months 

End Results:
  • Trial was enrolled within 14 months of RESolutions' involvement
  • Monthly patient enrollment increased from 5 to 22 on average
  • Patient retention was enhanced due to a more stable patient population
  • RESolutions increased the monthly patient enrollment rate from 5 to 22 on average

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