Statistical Analysis Plan

Statistical Analysis Plan

The Statistical Analysis Plan (SAP) brings the team together on the same page. For biostatisticians, all inferential analyses and statistical methods are delineated. For programmers, the SAP provides explicit guidance on SAS programming and the presentation of the tables, figures, and listings. For the sponsor, the SAP ensures they get the output they need for the clinical trial report. The SAP adds another layer of specificity to the project.

Working with the sponsor, we document and obtain agreement on the following:

  • Primary and secondary objectives, along with any possible changes
  • Sample size, randomization, and blinding
  • Disposition of study participants and definitions of populations: efficacy-evaluable, intention-to-treat (ITT), safety, and any sub-groups
  • Interim statistical analysis, methods for handling missing data
  • Demographics and baseline characteristics
  • Compliance to study drug or treatment
  • Method for analysis of efficacy endpoints
  • Evaluation of safety parameters