88 – Topics in Clinical Trials 2
Integrated Data Analysis for Assessing Treatment Effect Through Combining Information
Hui Quan
Sanofi
Bingzhi Zhang
Sanofi
Christy Chuang-Stein
Byron Jones
Novartis
It is critical to use a precise estimate of treatment effect when drawing conclusions, evaluating benefit/risk or designing a new study. Utilization of data from all sources in an integrated data analysis/meta-analysis will help us move closer to meeting this need. Depending on the data sources and objectives, there are many approaches for integrated analyses. These include network meta-analysis, multivariate meta-analysis, model-based meta-analysis as well as methods of borrowing historical data. In this paper, we discuss these methods with additional details for implementation and interpretation. We consider information adaptive repeated cumulative meta-analyses. We also discuss how to apply three integrated analysis approaches that take into account the variability of the overall treatment effect estimate to determine sample size for a new trial. Some computation and simulation results are provided.