The Data Safety Monitoring Board (DSMB) for the CLEAR-III clinical trial met today to review detailed data on the first 175 patients in the trial (152 post Day-180), with additional preliminary data from a total of 251 enrolled patients from across 61 clinical sites. CLEAR-III is a phase III clinical efficacy and outcomes study assessing the effect of external ventricular drainage (EVD) with rt-PA or placebo to treat intraventricular hemorrhage (IVH). The first subject, out of a planned 500, was enrolled in September 2009.
A formal report from the DSMB will be prepared and relayed to the clinical sites for submission to their local institutional review boards (IRBs) in a few weeks. Meanwhile, the coordinating center can report that the DSMB found no safety concerns and has recommended that the CLEAR-III trial be continued as planned. In personal comments, the board members complimented the investigators, coordinators, management team and the overall project team on conducting an exceptionally well run trial, with high quality data and one of the best safety profiles ever seen in this patient population.
The BIOS coordinating center will update the clinical sites once the final report is prepared by the board. Meanwhile, the study continues and we turn our attention to next year's meeting where the board will do a formal mid-study interim analysis, this time to include Day-180 outcomes data on the first 250 patients. The 250th patient was enrolled last month and will reach Day-180 next February. We will then need to collect and finalize all that data between now and next spring to get it ready for this analysis. On behalf of the management team, we express thanks to the investigators, coordinators and study site staff for their invaluable efforts in the conduct of this important clinical trial.