Paper SP08 Analyzing and Displaying Study Data in Clinical Trials Made Easy

Background: Quality of Life (QOL) research is becoming an increasingly integral part of oncology clinical trials. The inclusion of QOL endpoints provides an added uniqueness affecting analytical approaches and presentation of results. Objectives: We use North Central Cancer Treatment Group (NCCTG) oncology clinical trials design to provide examples of analysis techniques and demonstrate macros written to provide unique graphics for easily displaying patient and study outcomes. Methods: SAS ® macros have been developed for use in SAS v6 and higher to score QOL assessments, aid in the display of longitudinal data and provide summary statistics for study endpoints. We use a hypothetical trial with various endpoints to measure analysis of QOL at a single time point, change in QOL from baseline at a single point, maximum change from baseline, increase (or decrease) in individual QOL scores according to a definition of a clinically significant difference, time to event criteria and area under the curve (AUC). Results: The macros constructed provide versatility so that data can be displayed as per the programmers needs. The macro options allow the selection of either black/white or color graphics, controlling of axes, symbols and formats, printing of statistical results within some graphs, and formatting of graphics to display in mediums other than SAS/GRAPH. Conclusions: The presented macros have potential use in manuscripts, posters, presentations and grants and can be utilize