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.
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.
Equivalence Trial Design Principles
A practical guide to equivalence trial design, including equivalence margins, the two one-sided tests procedure, confidence intervals, sample size, power, Type I error, analysis populations, and a complete worked example.
Data Monitoring Committees: Role and Function
A practical guide to Data Monitoring Committees (DMCs), including their purpose, membership, independence, responsibilities, interim data review, stopping recommendations, confidentiality, unblinded statistical analyses, and the distinction between DMCs, sponsors, investigators, and regulatory authorities.
Crossover Trial Design and Analysis
A comprehensive guide to crossover trial design and analysis, including 2×2 crossover studies, treatment and period effects, sequence effects, carryover, within-subject comparisons, mixed-effects models, sample size, missing data, and a complete worked example.
Cluster Randomized Trial Design
A computational guide to cluster randomized trial design, including intracluster correlation, design effects, unequal cluster sizes, effective sample size, sample size inflation, analysis considerations, and a complete worked example.
Basket Trials in Oncology Research
A comprehensive guide to basket trials in oncology research, including biomarker-defined populations, multiple tumor types, independent and Bayesian hierarchical analyses, borrowing of information, multiplicity, operating characteristics, a complete worked example, and R implementation.
Alpha-Spending Functions: O’Brien-Fleming vs. Pocock
A practical guide to alpha-spending functions in group sequential clinical trials, comparing O
Adaptive Randomization Methods
A computational guide to adaptive randomization methods in clinical trials, including response-adaptive randomization, covariate-adaptive randomization, minimization, play-the-winner designs, Bayesian adaptive randomization, operating characteristics, type I error, power, allocation ratios, and implementation considerations.