A Day to Discover
“The Art of the Possible” with TransCelerate’s Digital Data Flow

The history of the TransCelerate Digital Data Flow (DDF) initiative has become well known across our industry. DDF grew out of the idea that information in a clinical trial Protocol could serve as a source of information for downstream documents and work products. The vision of increasing efficiency, reducing risk of errors, and enabling automated configuration of study systems has been compelling to many pharma companies and service providers across our industry, as well as to health authorities and other collaborations. As shown in Figure 1, the overall objective of DDF is to enable a change in how information flows across the ecosystem by supporting a shift to a fully digital protocol. DDF also hopes to more tightly link processes and data, and to enable the connection of metrics and predictive analytics that will allow for more data-driven study designs.

Figure 1. Objectives of TransCelerate’s Digital Data Flow Initiative.¹

Before the 2023 DPharm Conference in Boston, TransCelerate hosted a Discovery Day workshop that included member companies, DDF Leads, the fearless project management team from TransCelerate, and presentations from CDISC representatives and from the HL7-FHIR Vulcan Accelerator. The most important objective of the day was to explore current and potential use cases DDF solutions will support. The Nurocor Clinical Platform (NCP) was one of the featured demonstrations along with several other vendors.

The tagline for the day was “The Art of the Possible,” and the experience lived up to that billing.

The agenda started with a review of the evolution of the DDF project, from its inception to our current state. This included an overview of the key components and resources for DDF, including the USDM, the Study Data Repository, and resources in both the DDF and CDISC Github repositories. There was an emphasis on DDF’s critical partnerships with CDISC and the HL7-FHIR Vulcan Accelerator. As the CDISC Unified Study Definition Model (USDM) standard evolves from its current (R2) version to the next version, the standard will be extended with the intent of accounting for the full content of the ICH M11 Protocol template. The prospect that protocol specifications could be consistently represented and structured, according to well-governed data standards, from the point of collection in Electronic Health Records to final reporting in regulatory dossiers is something that wasn’t even conceived of just a few years ago.

The primary use case DDF was originally intended to support was the automated configuration of electronic data capture (EDC) and other clinical systems. Nurocor and other vendors previously demonstrated those capabilities. Companies have now also shown that the DDF Solution and the USDM can support other use cases that were not original priorities for DDF. To be clear, the USDM is definitely a “work-in-progress” and many elements of it remain to be fully defined. But even with those limitations, it was interesting to see it used i) to structure historical protocols to improve the utility of information in a searchable protocol library, or ii) to connect with detailed eCOA specifications for application in a decentralized trials platform, or iii) to structure study data for disclosures on clinicaltrials.gov.

I have had a front row seat and an active role in DDF for the past few years, and it has been exciting to play a part in its realization and evolution. This has enabled me to work closely with Nurocor and to understand the capabilities of NCP quite well.

Since my early exposure to the NCP as one of the Distinguished Submissions from the first DDF Hackathon in 2020, Nurocor has always been a leader and a vocal advocate, working to ensure DDF meets the needs of study design and downstream connection with EDC vendors. Nurocor’s involvement has ranged from being one of a small number of “collaborating vendors,” to successful participation in the 2022 Connectathon, once again being recognized as a Distinguished Submission. During the Discovery Day, Nurocor again demonstrated the ability of the NCP to effectively support the EDC automation use case. Nurocor’s presentation further demonstrated the capabilities of NCP as an upstream study definition provider covering study design, protocol elements, templated objectives and endpoints, the schedule of activities, and a workflow driven integration with the SDR.

While the DDF team has been clear on their core vision for their solution, whenever DDF engages with software- and service providers, we learn more about the potential of our solutions. We see great implementations of the core functionality that the team had envisioned (like NCP), and we also see use cases that broaden our appreciation for the products. Like all interoperability and open-source products, DDF will only prove successful when it is taken up by more providers, who provide their feedback on the use cases it supports, and on the improvements needed for it to be fully effective.

Reference

1. TransCelerate Biopharma Inc. DDF Overview Presentation. July 2023. Cited October 4, 2023. https://www.transceleratebiopharmainc.com/wp-content/uploads/2023/07/DDF-Overview_FINAL.pdf

Guest Contributor: Todd Georgieff

Todd has been working in Drug Development for more than 30 years, most recently having spent 15 years at Genentech and Roche. He has extensive experience in global clinical operations and has also held leadership roles in many large process improvement, technology, and organizational change initiatives.

In the past few years, Todd has been working on projects relating to the digitization of clinical research, both at Roche and Genentech and in several cross-industry collaborations. These include TransCelerate’s Digital Data Flow initiative, leading a clinical trial matching workstream for Precision Cancer Consortium, and supporting the automation of the Trial Master File.