Independent Data Monitoring Board Recommends Expedited Interim Analysis Of Overall Survival Data For Satraplatin Phase 3 Trial |
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As previously announced, following the interim efficacy analysis conducted on April 25, 2006, the DMB recommended that the SPARC trial continue as planned. The focus of that analysis was progression-free survival (PFS) and safety data. PFS remains the endpoint of the SPARC trial for accelerated approval in the U.S. and is also the basis, along with supporting overall survival data, for approval in Europe.
Spectrum and GPC Biotech do not have access to any of the data that caused the DMB to request this expedited review of overall survival, however, in its April 25th meeting, the DMB also had access to preliminary overall survival data. The companies are now, and will continue to remain, blinded to the data during this review process. The Data Monitoring Board consists of independent oncology and statistical experts whose primary responsibility is to monitor, on a periodic basis, the data from the SPARC trial and to provide recommendations to the companies on whether the study should proceed as originally planned, be modified or be discontinued for efficacy or safety reasons. Members of the DMB are independent from Spectrum and GPC Biotech and do not participate as clinical investigators in the SPARC trial. |
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Wed, Jul 21,2010
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