The Importance of Integrated Summary of Safety and Efficacy in Regulatory Review
The pharmaceutical and biotechnology industries are highly regulated, with numerous requirements for submission packages when applying for regulatory approval. The Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) are two key components of these submissions, providing a comprehensive overview of the safety and efficacy of a drug or product.
The submission package includes an Integrated Data Reviewer’s Guide (DRG) and integrated database(s) that enable reviewers to understand the traceability of data, pooling strategy, analysis considerations, subject-specific significant information, and conformance findings. This helps to ensure that the review process is thorough, efficient, and transparent.
The PHUSE Analysis Data Reviewer’s Guide (ADRG) is a widely adopted template used by sponsors to create a reviewer’s guide for a single study. However, PHUSE recognized that there was a need for a more standardized template for integrated analysis data submissions. In response, the integrated analysis data reviewer’s guide (iADRG) template was developed by the PHUSE project team, taking into account integration strategies, challenges, and regulatory recommendations.
The iADRG template provides structure and context for the integrated analysis data, making it easier for regulatory reviewers to understand the information presented. This is essential for the review process, as it ensures that all relevant information is presented in a clear and concise manner, making it easier for reviewers to assess the safety and efficacy of the product in question.
One of the key integration approaches considered in the development of the iADRG template was the pooling strategy. This refers to the process of combining data from multiple studies in order to improve the statistical power of the analysis. The iADRG template provides guidance on how to effectively pool data and present the results in a way that is easy for reviewers to understand.
Another key aspect considered in the development of the iADRG template was the analysis considerations. This refers to the various statistical methods and techniques used to analyze the data, and the iADRG template provides guidance on how to present the results in a clear and concise manner.
In conclusion, the ISS and ISE are vital components of a successful regulatory review submission, and the iADRG template provides a standardized approach to presenting the information. The iADRG template helps to ensure that the review process is thorough, efficient, and transparent, and that all relevant information is presented in a clear and concise manner. This benefits both the sponsors and the regulatory reviewers, as it leads to a more efficient and effective review process, helping to bring new treatments and products to market faster.
