For ISS/ISE, SCiAN will:

  • Develop a data specification plan to integrate (pool) safety and efficacy data across multiple studies within the program.
  • Implement the data specification plan to generate standardized datasets for analysis
  • Develop the statistical analysis plan and tables, listings and figures shells to assess safety and efficacy at the program level
  • Program the integrated safety and efficacy tables, listings and figures

With pooled ISS data, we can:

  • Identify common related adverse events and serious adverse events
  • Identify safety concerns that show a pattern across all studies
  • Assess safety in subgroups of subjects, if applicable

With pooled ISE data, we can:

  • Assess efficacy in subgroups of subjects (e.g. pediatric population)
  • Assess efficacy of secondary endpoint across all studies which would not have been possible under single studies
  • Explore inconsistency in results between studies
  • Assess sensitivity of results