Understanding How To Build And Leverage A DSMB Statistical Plan

This paper offers an overview of the essential components involved in providing independent statistical center support for a data safety monitoring board (DSMB), also known as a data monitoring committee (DMC). Statisticians and programmers utilize decades of expertise to design comprehensive DSMB statistical analysis plans (SAP) for clinical protocols. They provide the necessary programming and validation to produce the tables, listings, and graphs (TLGs) required by the DSMB and serve as the unblinded statistician on the board. Typically, DSMB statistical centers offer services such as developing DSMB SAPs, creating SAS-derived dataset programs, TLG programming, validating SAS programming according to 21 CFR Part 11 standards, preparing periodic statistical reports per SAP, and acting as unblinded statisticians on the DSMB.

Download the white paper below to better understand the role of the DSMB, the support provided by the statistical center, and the crucial role of the unblinded statistician in ensuring accurate assessments.