Spectral Diagnostics Inc. has announced that the Data Safety Monitoring Board (DSMB) for the EUPHRATES trial has completed its review of the detailed analysis it had previously requested.
Based on the current recommendations of the DSMB, the sample size has been recalculated and increased from 360 to 650 patients.
This increase in the number of enrolled patients enhances the likelihood of demonstrating, with sufficient power, a statistically and clinically significant effect. The revised sample size falls within the statistical plan already agreed to by the United States Food and Drug Administration (FDA). Spectral will also promptly submit a protocol amendment to the FDA, as recommended by the DSMB, for an additional exclusion criterion.
The EUPHRATES trial has continued to enrol patients and, as of April 11, 2014, 271 patients have been randomized.
"We are pleased with the positive outcome of the second interim analysis," said Dr. Paul Walker, President and CEO of Spectral. "The enthusiasm and support from our clinical trial sites has been outstanding. Based on current enrolment rates and number of sites, we anticipate completion of the trial in the first half of 2016."