Biostatistical topics

Clinical trial simulations (introduction to clinical trial simulations and Clinical Scenario Evaluation and key publications).
Subgroup analysis (confirmatory and exploratory subgroup analysis, software tools).

Working groups

Subgroup Analysis Working Group organized by Quantitative Sciences in the Pharmaceutical Industry (operating as part of the Society for Clinical Trials).
Biopharmaceutical Software Working Group organized by the Biopharmaceutical Section of the American Statistical Association.

Software tools

Mediana package (R package for general simulation-based power/sample size calculations).
Mediana Designer (free Windows-based software tool for traditional and simulation-based power/sample size calculations in fixed-sample and group-sequential trials).
Subgroup analysis software (open-source software tools for subgroup identification and analysis).

Special issues of biostatistical journals

Journal of Biopharmaceutical Statistics (June 2011) on multiplicity and adaptive design issues in pharmaceutical statistics.
Journal of Biopharmaceutical Statistics (January 2014) on subgroup analysis in clinical trials.
Therapeutic Innovation and Regulatory Science (January 2014) on advances in clinical trial statistics.