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.
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.
Seamless Phase II/III Adaptive Designs
A comprehensive guide to seamless Phase II/III adaptive clinical trial designs, including treatment selection, sample size adaptation, endpoint continuity, type I error control, combination of Phase II and Phase III stages, conditional power, and worked examples.
Sample Size Re-Estimation Methods
A practical guide to sample size re-estimation in clinical trials, including blinded and unblinded re-estimation, nuisance parameter adjustment, internal pilot designs, conditional power, promising-zone methods, type I error control, worked examples, and R implementation.
Response-Adaptive Randomization
A practical guide to response-adaptive randomization in clinical trials, including the basic concept, allocation probabilities, Bayesian response-adaptive randomization, ethical and statistical considerations, a complete worked example, and common pitfalls.
Platform Trials Explained
A comprehensive guide to platform trials, including master protocols, shared control groups, treatment-arm entry and removal, interim analyses, adaptive randomization, statistical multiplicity, operating characteristics, Bayesian and frequentist approaches, and a complete worked example.
Non-Inferiority Trial Design Principles
A practical guide to non-inferiority trial design, including the non-inferiority margin, hypotheses, confidence intervals, assay sensitivity, constancy assumptions, sample size, analysis populations, missing data, and a complete worked example.
Master Protocols in Clinical Research
A comprehensive guide to master protocols in clinical research, including umbrella, basket, platform, and multi-arm multi-stage designs, shared controls, statistical multiplicity, adaptations, estimands, operational considerations, and worked examples.
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