To be or not to be: decision making and scenario planning based on blinded clinical trial data

Music City Center 

Evidence-based quantitative decision-making is crucial at every stage of clinical development. Sponsors often look at ongoing clinical trial data either blindly or unblindly to make critical decisions. In this presentation, we focus on the discussion of interim analysis based on blinded data. Blinded data analysis is commonly performed during clinical trials to monitor the data quality, estimate the variation of currently observed data, or prepare the scenario planning before the final study readout. However, given the nature of the blindness, sometimes, the value of blinded analysis based on ongoing trial data could be limited for decision making. In this presentation, quantitative and visualization techniques to maximize the value of blinded analysis and support effective communication with senior management based on blinded data under quantified uncertainty are presented through a real clinical trial case study.

blinded data analysis

clinical trials

scenario planning 

Biopharmaceutical Section