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.
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.
Spider Plots for Tumor Response
A practical guide to spider plots for tumor response in oncology clinical trials, including longitudinal tumor burden, percent change from baseline, RECIST 1.1 response thresholds, patient trajectories, progressive disease, partial response, complete response, data preparation, interpretation, and R implementation.
Shift Tables for Laboratory Data
A practical guide to shift tables for laboratory data in clinical trials, including baseline-to-post-baseline changes, CTCAE grading, treatment-emergent abnormalities, denominator selection, interpretation, QC, and R implementation.
Kaplan-Meier Plot Best Practices
A practical guide to Kaplan-Meier plots in clinical trials, covering estimands, censoring, risk tables, confidence intervals, median survival, axes, numbers at risk, competing risks, subgroup displays, and R implementation.
How to Write a Statistical Analysis Plan (SAP)
A practical guide to writing a Statistical Analysis Plan (SAP) for clinical trials, covering estimands, analysis populations, endpoint definitions, missing data, intercurrent events, statistical methods, multiplicity, sensitivity analyses, safety, and TLF specifications.
Forest Plots for Subgroup Analyses
A practical guide to forest plots for subgroup analyses in clinical trials, including effect estimates, confidence intervals, interaction tests, multiplicity, subgroup definitions, interpretation, and R implementation.
Efficacy Table Development for Clinical Study Reports
A practical guide to developing efficacy tables for Clinical Study Reports, including endpoint definitions, analysis populations, denominators, descriptive statistics, treatment comparisons, confidence intervals, multiplicity, missing data, subgroup tables, and QC.