Bayer Transforms Clinical Trials with Digital Protocols

At the SCOPE EU conference, Julius Kusserow, an R&D Standards Expert at Bayer AG, presented a transformative vision for clinical trials through digitalizing clinical protocol information. This initiative, led by TransCelerate BioPharma Inc., aims to accelerate clinical research and enhance healthcare interoperability by shifting from a document-centric to a data-centric approach. This transition promises to streamline processes, reduce errors, and improve collaboration across the industry, ultimately benefiting patients.

From Documents to Data

The shift from a document-centric to a data-centric approach in clinical trials is a transformative change that promises to revolutionize clinical research. Traditionally, clinical trial protocols have been managed as static documents, which are cumbersome to update and share across platforms. Julius Kusserow highlighted the inefficiencies of this system, where each update requires manual intervention, leading to potential errors and delays. The new approach, “Write Once, Read Many Times,” aims to streamline these processes by creating a single digital version of the protocol accessible to multiple stakeholders simultaneously. This digital version is a static document and a dynamic, structured, machine-readable, and executable protocol. Once written, a protocol can be easily updated and shared across systems without repetitive manual input. This approach saves time and reduces errors, ensuring all stakeholders work with the most current and accurate information.

Industry-Wide Interoperability

One of the most significant challenges in clinical research is the lack of interoperability between different systems and organizations. Kusserow discussed how the digital data flow initiative aims to address this issue by fostering industry-wide interoperability. This involves creating a standardized digital representation of study protocols that can be easily exchanged between organizations, even those that do not typically cooperate. The goal is to enable seamless data exchange with minimal effort, breaking down the silos that often exist between different stakeholders in the clinical research process. By adopting a standardized approach, organizations can ensure that data is consistent and compatible across various platforms, facilitating collaboration and improving the efficiency of clinical trials. This interoperability is crucial for enabling the reuse of standardized protocol data, which can significantly reduce the time and resources required to conduct clinical research.

The USDM Standard

At the heart of the digital data flow initiative is the Unified Study Definitions Model (USDM) standard. This standard provides a comprehensive framework for ensuring consistency and clarity in clinical trial data. The USDM standard includes a UML logical model, which serves as a class diagram providing the basis for the standard. This model defines the structure and relationships between different data elements, ensuring that all stakeholders clearly understand the data being used. In addition to the logical model, the USDM standard includes CDISC-controlled terminology, which provides further semantics and complements the UML model. This terminology consists of the definition of classes and attributes and the definition of value sets, ensuring that all stakeholders use the same language and definitions when discussing clinical trial data. The USDM standard also includes an API specification, which provides the means to exchange a single study between machines using a JSON API. This allows for seamless data exchange between different systems, ensuring all stakeholders can access the most current and accurate data. The standardization the USDM provides is crucial for enabling the automation and AI-driven advancements that the digital data flow initiative promises.

Phased Evolution of DDF

The digital data flow initiative is being implemented in phases, with each phase building on the progress of the previous one. Between July 2021 and July 2022, Phase One laid the groundwork for the initiative by developing the USDM data model, API specifications, and implementation guides. This phase also included creating test files and conformance rules, which are essential for ensuring the standards are implemented correctly. In addition to these foundational elements, Phase One introduced several tools to facilitate protocol development and connectivity to downstream systems. These tools include the Study Definitions Repository (SDR), a centralized repository for study definitions, and the Common Protocol Template (CPT) Interface Tool, which provides a standardized template for creating clinical trial protocols. These tools are designed to streamline the protocol development process, making it easier for stakeholders to create and share protocols. The phased approach to implementing the digital data flow initiative ensures that each element is thoroughly tested and refined before being rolled out to the broader industry. This careful, step-by-step approach is crucial for ensuring the initiative’s success and building confidence among stakeholders in the new system.

Use Cases and Benefits

The digital data flow initiative is set to revolutionize various aspects of clinical trials, offering numerous benefits to different stakeholders. The initiative enables medical writers to work more efficiently within a single digital study design system. This system allows them to access and update study content in real-time, reducing the time and effort required to create and update protocols. Data managers also benefit from digitalizing end-to-end processes, from study design to electronic data capture (EDC). The structured data generated by these processes can be leveraged to track outcomes and monitor progress, providing valuable insights into the effectiveness of clinical trials. Technical experts, on the other hand, can focus on more complex projects that cannot be automated, thanks to the reduction in tedious manual work. By freeing up time for value-added activities, the digital data flow initiative allows technical experts to contribute more effectively to the success of clinical trials. Overall, the initiative promises to improve clinical trials’ speed, quality, and consistency by enabling automation and AI-driven advancements.

Looking Ahead

The conference highlighted several upcoming opportunities for stakeholders to engage with the digital data flow initiative. These include the PHUSE EU Connect 2024, and the DDF Solution Showcase Webinar Series, which will provide further insights into the evolution of digital data flows in clinical trials. These events offer stakeholders the chance to learn more about the initiative, share their experiences, and collaborate with others in the industry. Digitalizing clinical protocol information represents a significant leap forward for the clinical trials industry. By embracing a data-centric approach, the digital data flow initiative promises to enhance efficiency, interoperability, and innovation in clinical research, ultimately benefiting patients.