ADaM for Clinical

Analysis of Clinical trials is a necessary step to assess the efficacy and safety of novel therapeutics. The Analysis Data Model (ADaM) is an exchange standard of the Clinical Data Interchange Standards Consortium (CDISC) standards, designed to hold the as-collected data from the patients in a manner consistent with the rules specified in the Statistical Analysis Plan. ADaM datasets play a pivotal role in facilitating the generation of statistical analyses, regulatory submissions, and reproducible research in clinical trials.

• Analysis-Ready Datasets:
  ADaM datasets structure as-collected SDTM data in a form that is analysis-ready, allowing seamless execution of statistical models, efficacy evaluations, and safety analyses. Flags are provided to make it easy to run analysis scripts.
• Traceability:
  ADaM datasets link directly to the Study Data Tabulation Model (SDTM) datasets and source data, ensuring a clear audit trail for regulatory compliance and reproducibility.
• Standardized Structure:
  ADaM provides a standardized framework that includes:
  • ADSL (Subject-Level Analysis Dataset): Contains demographic and treatment information.
  • BDS (Basic Data Structure): Supports longitudinal and time-to-event analyses.
  • OCCDS (Occurrence Data Structure): Handles event-based data, such as adverse events.
• Regulatory Compliance:
  ADaM is endorsed by regulatory agencies such as FDA (U.S.) and PMDA (Japan), ensuring compatibility with submission requirements.

Xbiom MDR and Smart Transformation modules support generating compliant exchange data sets such as Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) that ensure data consistency, reliability, and traceability. The main goal in creating analysis standards is to have the optimum number of analysis datasets needed to perform various analyses.

These analysis datasets are stored in the repository, namely the Universal Data Model, that is matured to the Data Services Layer. This layer includes view-ready research data that may be utilized for various analyses with a single dataset, as well as metadata indicating imputation, end-point derivations, and cohort selections.

As part of the regulatory submission package, the Xbiom MDR and Smart Transformation can also generate ADaM artifacts define.xml, Reviewer’s Guide and ADaM validation rules (CDISC/FDA/PMDA). Validation of analysis data for compliance with regulatory standards is an important step in submission pathways. With the support of the onboard eDataValidator and “intelligent automation,” XBIOM validates the SDTM or ADaM data product, offering a number of validation cycles to ensure data quality throughout the standardization process.