ISS/ISE

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