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Why invivodata > Case Studies > Sepracor
Sepracor, Inc. – 23% Increase in Study Power
Therapeutic Category: Overactive Bladder
Result: 33% reduction in error variance and 23% increase in study power compared to a paper-based diary trial
Value to Sepracor: 50% reduction in sample size on next trial
Description: Results showed a 33% reduction in error variance compared to an earlier study of the same compound using paper diaries. Eliminating recall bias using invivodata's eDiary system increased study power from 80% to 98% which is unmatched in the industry.
This dramatic increase in the sensitivity of the data collected using the invivodata ePRO system will enable Sepracor to use half the number of subjects and reduce the duration of their next Phase III clinical trial by an estimated 8 months.
invivodata worked collaboratively with Sepracor on the ePRO system that required subjects to enter multiple events every day for 14 weeks as they occurred. The results showed that the eDiary system dramatically increased the integrity of the patient recorded outcome data by driving over 90% patient compliance and, as a result, reducing error variance by 33%.
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