Integrated Data Analysis for Assessing Treatment Effect through Combining Information from All Sources |
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Authors: | Hui Quan Bingzhi Zhang Christy Chuang-Stein Byron Jones On behalf of the EFSPI Integrated Data Analysis Efficacy Working Group |
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Institution: | 1. Biostatistics and Programming, Sanofi, Bridgewater, NJ;2. Chuang-Stein Consulting, Kalamazoo, MI;3. Novartis, Basel, Switzerland |
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Abstract: | It is critical to use a precise estimate of treatment effect when drawing conclusions, evaluating benefit/risk, or designing a new study. Using 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 article, we discuss these methods with details for implementation and interpretation. In addition, we consider information adaptive repeated cumulative meta-analyses. We also discuss how to apply three approaches that take into account the variability of the overall treatment effect estimate obtained through integrated analysis to determine sample size for a new trial. Some computation and simulation results are provided. |
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Keywords: | Historical data Meta-analysis Sample size calculation Surrogate endpoint |
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