The Data and Safety Monitoring Board: The Toughest Job in Clinical Trials
Scott Evans, Lijuan Zeng, Weixiao Dai
Abstract
The DSMB: The Toughest Job in Clinical TrialsIn this review article, the authors discuss methods that DSMBs can use to compare the absolute and relative risks of benefits and adverse effects between trial interventions and illustrate how the DSMB can use this approach to evaluate the balance of these competing risks. Two approaches are discussed - the win ratio and the DOOR probability on one treatment relative to another.
Topics & Concepts
Ranking (information retrieval)Relative riskOutcome (game theory)Risk analysis (engineering)Safety monitoringPsychological interventionComputer scienceBalance (ability)MedicineStatisticsConfidence intervalMathematicsMachine learningPhysical therapyPsychiatryBiologyMathematical economicsBiotechnologyStatistical Methods in Clinical TrialsHealth Systems, Economic Evaluations, Quality of LifeMeta-analysis and systematic reviews