Youden Index for Optimal Cutpoints
A practical guide to the Youden Index for selecting optimal diagnostic and biomarker cutpoints, including ROC curves, sensitivity, specificity, threshold selection, worked examples, limitations, validation, and R implementation.
Writing the Statistical Section of a Clinical Study Report
A practical guide to writing the statistical section of a Clinical Study Report, including analysis populations, endpoints, estimands, statistical methods, missing data, multiplicity, confidence intervals, subgroup analyses, sensitivity analyses, protocol deviations, and clear CSR reporting.
Waterfall Plots for Oncology Trials
A practical guide to waterfall plots in oncology clinical trials, including tumor change from baseline, RECIST 1.1 interpretation, response thresholds, data preparation, ordering, handling progressive disease, limitations, and R implementation.
Understanding Minimal Clinically Important Difference (MCID)
A practical and computational guide to the Minimal Clinically Important Difference (MCID), including anchor-based and distribution-based methods, responder definitions, confidence intervals, sample size implications, interpretation, and clinical trial examples.
Understanding ICH E9 Statistical Principles
A practical guide to ICH E9 and ICH E9(R1) statistical principles for clinical trials, including trial objectives, endpoints, estimands, randomization, analysis populations, bias, missing data, multiplicity, interim analyses, sample size, sensitivity analyses, and reporting.
Umbrella Trials Explained
A comprehensive guide to umbrella trials in precision oncology, including biomarker-defined treatment arms, master protocols, treatment assignment, statistical design, multiplicity, adaptive decision-making, operating characteristics, and a complete worked example.
Table, Listing, and Figure (TLF) Development Basics
A practical guide to Table, Listing, and Figure (TLF) development for clinical trials, covering TLF shells, analysis populations, statistical outputs, formatting conventions, validation, QC, traceability, and common programming pitfalls.
Swimlane Plots in Oncology Reporting
A practical guide to designing, interpreting, and reporting patient-level swimlane plots in oncology clinical trials, including treatment exposure, tumor response, progression, dose modifications, and ongoing follow-up.
Subgroup Analysis: Regulatory Expectations
A practical guide to subgroup analysis in clinical trials, including FDA and EMA regulatory expectations, prespecification, treatment-by-subgroup interactions, heterogeneity, multiplicity, demographic subgroups, forest plots, small sample sizes, interpretation, reporting, and implementation in R.
Stepped-Wedge Trial Design Explained
A practical guide to stepped-wedge cluster randomized trial design, including rollout sequences, clusters and periods, intracluster correlation, treatment effects, sample size, power, analysis models, efficiency, and a complete worked example.