Case study: The REALI pooled analysis of the European post-marketing studies for the TOUJEO® product

The purpose of the REALI pooled analysis is to advance the understanding of the effectiveness and real world safety of insulin Gla-300 based on a large European patient database of post-marketing interventional and observational studies.

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This study aims to identify and understand the variation in patients’ experiences when treated with Gla-300, and to gauge selected patient characteristics that may be of interest to describe subsets of European populations with diabetes. To achieve these goals, the Sponsor uses two complementary statistical approaches, which enhance the chance of correctly identifying subgroups of patients with specific effectiveness and real-world safety patterns. Highlighting the profiles of patients who achieve greater glycaemic control will allow clinicians to provide personalized treatment plan to patients with diabetes.

IDDI TASKS :

  • Statistical Analyses Plan
  • SDTM Mapping for the pooling
  • Statistical Programming
  • Statistical Analyses

IDDI SOLUTIONS :

  • IDDI produced statistical reports at overall and at subgroups level enabling the Sponsor to compare the results with the local CSR.
  • IDDI performed two sets of programs quality control and data homogenization at Data Management and at Statistical level in order to identify missing data and work on equivalent variables
  • IDDI provided a substantial support in terms of statistical data review and data equivalence improving the quality of analysis

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Case study: The REALI pooled analysis of the European post-marketing studies for the TOUJEO® product