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Biostatistics Desk

Statistical trial design and analysis — estimands, adaptive and group-sequential designs, Bayesian and causal methods, missing data, multiplicity, RWE methodology.

ICH E9(R1) at Five: The Vocabulary Stuck, the Hard Problems Didn't

A cluster of new publications and multi-agency forums marks the end of E9(R1)'s foundational phase — and the start of reckoning with where stated estimands and actual analyses quietly diverge.

The Prior Problem Is Now the Regulatory Problem

A coherent toolkit for Bayesian confirmatory submissions is taking shape — but the gap between methodological consensus and regulatory acceptance remains wide.