Yasuharu Shibata, Director, Clinical Data Management, MSD KK

Today, clinical study startup requires a highly manual process to configure systems/tools with inconsistently specified inputs and data. The nature of protocols and associated processes also mean that sponsors generally lack a reliable method to sync updates from a single source of truth. Manual approaches stifle speed and limit innovation, making industry’s ambitions to modernize clinical trials more difficult.
The Digital Data Flow (DDF) initiative aims to address these challenges by moving the drug development process from a manual study start-up asset creation to a fully automated, dynamic, study start-up readiness. Join us to understand how DDF enables an automated, dynamic, study start-up readiness, via the foundational data model, the Unified Study Definitions Model (USDM), developed by CDISC in partnership with TransCelerate, to:
• digitize a real protocol
• enhance the downstream benefits of protocol digitalization
• provide a streamlined, automated study start-up (reduce effort, cycle time, and complexity)
• improve quality, compliance and minimize protocol violations

Ippei Akiya, ICON Clinical Research GK, Biometrics

In clinical trials for drug development, statistical analysis is typically performed using SAS or R, and Tables, Figures, and Listings (TFLs) are created as components of a Clinical Study Report. These TFLs are usually output to RTF or PDF files using SAS or R. However, the CDISC Analysis Results Standard (ARS) introduces a new approach that integrates the Result Data and Metadata of the analysis results, allowing TFLs to be output to RTF or PDF files from this integrated source. To manage this integration of Data and Metadata, the LinkML Linked Data modeling tool is employed in CDISC ARS. Drawing on my experience with Linked Data, I will demonstrate CDISC ARS from the perspective of a Linked Data user, presenting an overview of the workflow, required skill-set, and potential applications. Additionally, I will offer several recommendations to support the future development of CDISC ARS.