Pharmaceutical Statistics Using SAS

Appendix A Guidelines for "Statistical Considerations" Sections

A well-developed statistical considerations section persuades reviewers that solid skill and effort have gone into framing the research questions, planning the study, and forming an appropriate team. The writing should be crafted for the clinical researcher who is a good "para-statistician," as well as for the professional biostatistician. The "Statistical Considerations" section should be mostly self-contained and thus may reiterate information found elsewhere in the proposal.

A.1 Components

Design. Summarize the study design. It may be helpful to use appropriate terms such as randomized, double blind, crossover, controlled, comparative, case-control, prospective, retrospective, ...