Trends and Innovations in Clinical Trial Statistics conference (TICTS 2014)

Regulatory guidance

Regulatory guidance documents

Software tools

Mediana package (R package for general simulation-based power and sample size calculations).
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.

Biostatistical topics

Subgroup analysis (confirmatory and exploratory subgroup analysis, software tools).

Working groups

QSPI Subgroup Analysis Working Group