Bio.dy/dx

Practical biostatistics for clinical development — adaptive design, Bayesian methods, early phase oncology, and IVDs, built on 13+ years of hands-on trial design and regulatory experience.
Published

March 13, 2026

Biostats insight, opinion and tools for clinical development.

Trial design, analysis, biomarkers, and simulation in R. By Paul Steven.

Practical insights in clinical trial design, complex endpoints, and biomarker-driven development — drawn from 13+ years across early phase oncology, rare disease, IVDs, and companion diagnostics.

Expertise

Trial Design

Bayesian adaptive designs for early phase trials — dose escalation (BOIN), dose optimisation (MATS), basket trials, and adaptive enrichment. IVD and analytical studies utilizing device endpoints.

Complex Endpoints

Non-standard and translational endpoints including PD, ctDNA, MRD, and analytical device output. Statistical strategy aligned with underlying science and regulatory expectations.

Simulation in SAS and R

Simulation frameworks for dose-response, biomarker thresholds, and design operating characteristics. R/Shiny tools for interactive exploration of Bayesian models.

Latest Insights

19 Mar 26

Adaptive Enrichment Explorer

Interactive R/Shiny app for simulating adaptive enrichment in biomarker-driven oncology trials.

Open Tools & Demos →

13 Mar 26

Adaptive Enrichment in Biomarker-driven Oncology

A practical explainer of adaptive enrichment in biomarker-driven oncology, illustrated with a single-arm Bayesian phase 2 example.

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