CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation

Abstract

The use of standardized data formats has increasingly facilitated both the submission of clinical trial data by pharmaceutical companies and its review by regulatory agencies. The Clinical Data Interchange Standards Consortium (CDISC) format has become the de facto worldwide standard for clinical trial data submissions and review. CDISC data are captured and organized in defined datasets, or domains, with predefined variable names and attributes. As a result, researchers and reviewers have a consistent, repeatable, and rapid way to load, review, and analyze data. The benefits provided by this standardization have culminated in the development of software that intuitively utilizes CDISC structures to quickly import and analyze the data as well as summarize the results for scientists and clinicians in a collection of readable and easy-to-understand reports. In this paper, we will show how CDISC datasets with their required domains and respective variables can be utilized by JMP® Clinical to create clinical trial analysis reports easily and quickly with interactive graphs and tables for use in FDA New Drug Applications and Clinical Reviews. These reports are also ready for inclusion in regulatory submissions such as regulatory documents and clinical study reports to improve reviewability, interpretability, and efficiency of regulatory submission and review.