Analysis results play a crucial role in the drug development process, providing essential information for regulatory submission and decision-making. However, the current state of analysis results reporting is suboptimal, with limited standardization, lack of automation, and poor traceability. Currently, analysis results (tables, figures, and listings) are often presented in static, PDF-based reports that are difficult to navigate and vary between sponsors. Moreover, these reports are expensive to generate and offer limited reusability. The CDISC Analysis Results Standard (ARS) has been developed to support consistency, traceability, and reuse of results data.
Large trials and studies generate many analysis results in the form of tables, figures and written reports, but they are rarely output in a form that is machine-readable, and there has been no standard way of describing and organizing these results. This makes it difficult to automate their generation, make them reproducible, trace their origin or enable them to be reused in other outputs. While the CDISC Define-XML standard does includes structures to hold Analysis Results Metadata (ARM), this is limited in scope and is generated after the TFLs are produced. The main purpose of ARM was to provide traceability from the TFLs to the ADaM datasets and example of the current workflow is seen below.
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