3 Types of Interim Analyses: SAFETY, FUTILITY, EFFICACY. (SAFETY being a continuous DMC concern).
During a clinical trial, we can perform interim analysis (or DMC, DSMB review) for 3 different reasons:
Interim analysis for SAFETY: 1) with pre-specified stopping rule (for example stop the trial if we see # of cases of Serious Adverse Events) 2) without pre-specified stopping rule (rely on DMC members to review the overall safety)
Interim analysis for FUTILITY ["INFERIORITY"]: To see if the new treatment is unlikely to beat the control – then stop the trial for futility - this is called ‘futility analysis’.
Interim analysis for EFFICACY ["SUPERIORITY"]: To see if the new treatment is overwhelmingly better than control - then stop the trial for efficacy.
In situations 2 & 3, the criteria for stopping rule for efficacy could be different from the stopping rule for futility, but need to be pre-specified.
= = = = = = = 6-1-15 PR: BAVI CLINICAL TRIALS EXPANSION http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=915699 SUNRISE Phase III Pivotal Trial The company's Phase III SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) is an approximately 600 patient trial that continues to enroll at over 150 sites worldwide. Completion of enrollment is anticipated by calendar year-end. This Phase III, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety, tolerability and efficacy of bavituximab as a second-line treatment in patients with non-squamous NSCLC. Enrollment is proceeding according to plan with 2 planned interim efficacy analyses which will be reviewed by the trial's Independent Data Monitoring Committee (IDMC). The 1st interim analysis, which will be conducted when 33% of the targeted overall survival events are reached, is for futility and the 2nd interim analysis, for futility or superiority[Superiority=EFFICACY], will be conducted at 50% of events. As these analyses are event driven, the exact timing of each is unknown, however the company plans to provide updates as these events are reached. For additional information about the SUNRISE trial, please visit http://www.sunrisetrial.com or ClinicalTrials.gov using the Identifier NCT01999673. => http://www.clinicaltrials.gov/ct2/show/NCT01999673
12-10-15: “Sunrise >90% enrolled; sufficient to allow the 2 planned interim looks (33%/50%) and final readout based on PrimEndPt=OS” “The next milestones are the interim analyses that will be conducted when 33% & 50% of the targeted number of deaths are reached. While these are event driven, it is our expectation that the 1st interim analysis will read out in early 2016 and the 2nd interim analysis around mid-2016. The final analysis, which will trigger study unblinding, is currently projected to occur at the end of 2016. http://tinyurl.com/jkp885g
Market Data 
Markets 
AI
