Clinical Research Design and Biostatistics

Sound statistical design is an essential component of a scientifically valid study. The ICSSC Biostatistics staff can provide statistical review or consultation during any stage of clinical research:

  • Concept plan development
  • Study design consultation
  • Protocol development
  • Sample size determination
  • Design of randomization and treatment allocation procedures
  • Preparation of detailed analysis plan
  • Preparation of data and safety monitoring plan
  • Case report form development
  • Programming of randomization scheme
  • Definition of data quality checks
  • Selection of statistical software
  • Interim analysis and preparation of reports for Data and Safety Monitoring Board
  • Final analysis of data and interpretation of results
  • Preparation of manuscripts

View presentations from past ICSSC events for information on Biostatistics in clinical research.