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.
Introduction to Adaptive Clinical Trial Designs
A practical introduction to adaptive clinical trial designs, including prespecified adaptations, sample size re-estimation, adaptive randomization, arm dropping, seamless Phase II/III designs, interim analyses, statistical validity, operational considerations, and regulatory principles.
Interim Analysis Planning and Stopping Rules
A practical guide to planning interim analyses in clinical trials, including information fractions, efficacy and futility stopping rules, alpha spending, O
ICH E9(R1) Estimands: Practical Implementation
A practical guide to implementing ICH E9(R1) estimands in clinical trials, including the five estimand attributes, intercurrent events, treatment-policy, hypothetical, composite, while-on-treatment and principal-stratum strategies, estimators, sensitivity analyses, SAP implementation, and practical examples.
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.
Group Sequential Designs Explained
A practical guide to group sequential clinical trial designs, including interim analyses, efficacy and futility boundaries, alpha spending, O
Futility Analysis in Clinical Trials
A practical guide to futility analysis in clinical trials, covering non-binding and binding futility, conditional power, predictive power, information fraction, interim decision rules, sample size re-estimation, operating characteristics, worked examples, and implementation in R.
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.
Fleming’s Two-Stage Design: A Worked Example
A computational guide to Fleming
Factorial Clinical Trial Designs
A practical guide to factorial clinical trial designs, including 2×2 factorial designs, main effects, interaction effects, randomization, sample size, treatment combinations, analysis, interpretation, missing data, multiplicity, and a complete worked example.