T-43: Combining Tabular Data with Visual Display to Enhance Interpretation of Clinical Trial Data

Poster Presenter

Teresa Curto

Associate Director, Biostatistics
Cytel
United States

Objectives

This presentation will demonstrate how tabular and graphic data was used to determine the treatment effect of a phase 3 clinical trial study drug and to examine whether particular study sites responded differently.

Method

Tables were used to present the overall treatment effect. Forest plots showing mixed model for repeated measures (MMRM) effect size were produced, allowing us to look at differences among sites by study visit. By-site spaghetti plots were created to look at outcomes by treatment group over time.

Results

Tabular data showed a statistically significant positive treatment effect. Graphic data stratified by study site showed that one large study site had treatment outcomes that were shown to be driving overall results. This information was used to examine whether there were patient characteristics or site issues that contributed different outcomes for subjects at that study site.

Conclusion

Visual display of clinical trial data can supplement tabular data to determine if and how subgroups impact the results of clinical trials.