Digital Data Flow Discovery Day: The “Art of the Possible”

On the eve of this year’s DPharm conference, TransCelerate hosted its first Digital Data Flow Discovery Day in Boston. The goal of the event was to raise awareness, exchange knowledge, and convene stakeholders from around the R&D industry to demonstrate the implementation of its Digital Data Flow (DDF) solutions, the Unified Study Definitions Model (USDM), and the Study Definitions Repository (SDR).

Clinical protocol design is generally an electronic form of paper and is limited in having a structured data format that other systems can easily leverage. In today’s data-driven world, now is the time to seize the opportunity of a digital-first approach focusing on “Write once, use many times.”

Over the past three years, TransCelerate’s DDF Initiative, in collaboration with CDISC, has delivered a foundational Unified Study Definitions Model (USDM), an open-source Study Definitions Repository (SDR) Reference Implementation aimed at supporting the widespread use of digital protocols across the industry, and accompanying CDISC standards. Earlier this year, Versions 2.0 of the CDISC USDM and SDR were released with key enhancements, including automated electronic data capture set-up and common protocol template export.

“I know change is coming and I want to be part of the dialogue”

This face-to-face event brought together 17 TransCelerate Member Companies, seven clinical solution providers applying one of the DDF solutions, and other key industry stakeholders from CDISC and the HL7 FHIR Vulcan Accelerator for an interactive experience to raise awareness and exchange knowledge around the implementation of the DDF solutions.   

To create a robust experience, the DDF Discovery Day included explorations of practical applications of the DDF solutions, moderated discussions of transformational enablers and potential hurdles, and presentations on the future roadmap for DDF as the initiative is converging with many standards-related efforts in the ecosystem, including the advancement of ICH M11 CeSHarP and research-to-care interoperability through the Vulcan FHIR Accelerator under HL7.

The day was split between meaningful group discussions and workshops and one-on-one engagements. The agenda allowed multiple opportunities for participants to exchange perspectives, discuss use cases, and learn about tools and resources. The audience was highly engaged, with TransCelerate members rotating through the provider showcase exhibits and learning about the landscape of options. It was apparent that the audience recognized that putting DDF into practice is now a real and present opportunity. Attendees shared their enthusiasm with each other, sharing sentiments such as,

• “I had very little understanding of DDF before today, so each session gave a different perspective and deeper dive. I thoroughly enjoyed it.”
• “I know change is coming, and I want to be part of the dialogue.”
• “For someone who has just started the DDF journey from my organization, this single-day event helped me get a better understanding and perspective of what we are doing and why we are doing it. Some great ideas were exchanged on having a community of sponsor companies.”

To close out the day, attendees gathered for roundtable discussions and shared insights on implementing this type of digital transformation. Some common themes stood out:

• Leadership is key and may require leadership from different groups working together
• Cross-functional collaboration is critical. As DDF is designed to span multiple functions, it’s essential to include both strategic and tactical operations professionals across relevant departments
• Similarly, because the data flow starts with clinical and medical writing, it is key to get these professionals involved
• Business cases on the positive impact for DDF can help accelerate implementation, as regulatory mandates typically drive change within an organization
• CDISC and M11 standards help to bridge the relationship between research and clinical care
• Tailored education and training per stakeholder not only helps with “buy-in” to the DDF concept but also helps to ensure that those who can benefit from this solution feel empowered to execute it

All in all, the first-ever DDF Discovery Day was a huge success, with future events planned. As a result of the event, it became apparent that DDF implementation is further along than expected. A post-event survey indicated that all respondents are interested in attending a future event.

Thank you to everyone who participated. A post-event summary and conclusions readout will be published soon on the DDF site. To learn more about how to get involved or approach it in your organization, visit the Digital Data Flow GitHub page.