Co-authors: Joshua Betz (Johns Hopkins Bloomberg School of Public Health), Kelly Van Lancker (Ghent University), Joshua Betz (Johns Hopkins Bloomberg School of Public Health), Michael Rosenblum (Johns Hopkins University, Bloomberg School of Public Health)

Randomized Trials Covariate Adjustment Adaptive Designs Sample Size Re-estimation Information Monitoring Group Sequential Designs

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

11:35 AM - 11:50 AM

Co-authors: Shihua Wen (Novartis), Nicolas Ballarini (Novartis), Shihua Wen (Novartis)

blinded data analysis clinical trials scenario planning

Unblinding risk score: a measure of risk for guessing the treatment group in blinded studies

11:50 AM - 12:05 PM

Co-authors: Wenjun Zheng (Regeneron Pharmaceuticals), Bret Musser (Regeneron), Wenjun Zheng (Regeneron Pharmaceuticals)

Clinical trials data masking unblinding risk assessment randomized double-blinded placebo-controlled studies unblinding risk