FDA Guidance on Missing Data in Clinical Trials
A practical guide to FDA expectations for preventing, documenting, analyzing, and assessing the sensitivity of missing data in clinical trials, including estimands, intercurrent events, MAR and MNAR assumptions, multiple imputation, pattern-mixture models, tipping-point analyses, and clinical-trial reporting.
FDA Guidance on Adaptive Trial Designs
A practical guide to FDA
Essential Skills for a Clinical Biostatistician
A practical guide to the essential skills for a clinical biostatistician, covering statistical methods, clinical trial design, programming, CDISC, data standards, regulatory reporting, communication, critical thinking, quality control, and career development.
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.
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.
EMA Statistical Guidance Overview
A practical overview of EMA statistical guidance for clinical trials, including ICH E9, estimands, multiplicity, missing data, subgroup analysis, covariate adjustment, survival analysis, adaptive designs, confirmatory trials, and practical implementation.
Disposition Tables: CONSORT-Style Reporting
A practical guide to disposition tables and CONSORT-style participant-flow reporting in clinical trials, including treatment exposure, discontinuation, study completion, analysis populations, denominators, reconciliation, QC, and R implementation.
Diagnostic Test Accuracy Meta-Analysis
A practical guide to diagnostic test accuracy meta-analysis, including sensitivity, specificity, likelihood ratios, diagnostic odds ratios, forest plots, ROC space, SROC curves, HSROC and bivariate models, heterogeneity, threshold effects, study design, data preparation, and R implementation.
Demographics and Baseline Characteristics Tables
A practical guide to demographics and baseline characteristics tables in clinical trials, including categorical and continuous summaries, denominators, missing data, baseline definitions, treatment-group presentation, 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.