The Protocol The Biometrics Weekly

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Biostatistics

Data Management

Three percent of Dryad datasets fail a duplication scan — and that's just the pilot

Three converging items this week reframe source-data trust as the binding constraint on the preclinical, biomarker, and repository data that ultimately feeds regulatory submissions.

CNS trials reach for Bayesian neurophysiology while blinding quietly leaks

A semaglutide-for-cocaine protocol, a scoping review on active placebos, and an EMA concept paper on smoking cessation all land in the same week — and all point at the same unresolved problem.

Regulatory & Conduct

The open-data literature now has a measured contamination rate

Spick et al. put a number on the paper-mill exploitation of FAERS, NHANES, UK Biobank and the rest — 11,577 excess publications in 2025 — just as EMA's concept paper on external controls lands.

The OS Toolkit Arrives Just as ASCO Stress-Tests It

SBR's special section gives oncology biostatisticians a coordinated framework for OS monitoring, safety, and interim looks — and ASCO 2026 supplied the awkward case studies before the ink dried.

The Win Ratio's Methodology Bill Comes Due

A simultaneous wave of papers formalizes the win ratio's pathologies — including a 2×2 reversal in which treatment beats control on every component and still loses overall — while cardiovascular sponsors keep pre-specifying it as primary.

Bayesian Borrowing Methods Converge on a Single Problem: Defending Type I Error

Across four journals in one cycle, independent groups are re-engineering robust mixture, power, and synthetic priors with frequentist error control as the design constraint — not the afterthought.

Response-Adaptive Randomization Tries to Answer Its Critics

A previously unpublished Zhu–Rosenberger response to the 2011 Korn–Freidlin critique surfaces alongside seven new RAR papers — the field is plugging the operational holes regulators have been pointing at for a decade.