Today, the clinical trial protocol – which serves as an anchor for specifying clinical trial requirements and parameters – does not exist in a common, machine-readable format which can be easily exchanged among disparate systems. Currently, there exists an average lag time of four months between protocol completion and study start. Furthermore, third-party conversion of data to Study Data Tabulation Model (SDTM) lengthens cycle time and presents limits for traceability and re-use. Finally, working in a document-based environment results in significant manual duplication of effort.
By starting with an industry standard data format for use during study design, the Digital Data Flow initiative offers a mechanism to digitize clinical study components to enable automation, interoperability, and reuse across the study lifecycle.
The initiative will help to modernize clinical trials by enabling a digital workflow to allow for the automated creation of study assets and configuration of study systems to support clinical trial execution. This initiative will establish a foundation for a future state of automated and dynamic readiness that can transform the drug development process.
TransCelerate has collaborated with CDISC and other stakeholders to develop a standard data model for specifying protocol information, as well as a demonstrated way to connect systems that produce, exchange or consume this information.
Our pragmatic approach centers around 4 key principles:
- Throughout the process, we are engaging with implementers – including sponsors, technology vendors and CROs – who play a critical role in adopting standards into their software and digitalization roadmap.
- Our solutions are provided under an open-source license for anyone to freely use, providing a vendor-agnostic, platform-independent blueprint for end-to-end digitalization.
- We are preparing to transition the initiative to appropriate third parties for long term governance and sustainability.
- Lastly, we are closely engaged with existing, related work such as TransCelerate’s Clinical Content & Reuse (CC&R), ICH M11, and the Vulcan FHIR Accelerator, with the objective of unifying rather than proliferating standards.
Our approach leverage and seek to unify resources that already exist today, including but not limited to:
- TransCelerate’s CC&R initiative and the Common Protocol Template Resources
- ICH M11 Protocol Template and Technical Specification
- Vulcan FHIR Accelerator and FHIR Implementation Guide for Schedule of Activities
- Implementation of standards developed out of the DDF initiative by sponsors, CROs and technology vendors can enable:
- Harmonized data exchange between systems: leading to a significant reduction in manual curation of protocol information
- Process automation: automated set-up of existing and future systems used to execute a study (e.g., EDC, CTMS, EHR, DCT software)
- Advanced analytics: supporting objectives such as smart study design, predictive risk modeling, feasibility, etc.
- Greater flexibility to plug-and-play across a variety of clinical systems and a reduction in cost and time for bespoke integrations
The return on investment of solutions delivered through the DDF initiative will be measured in reduced costs, reduced cycle times, and net-new value creation.
Available assets include:
- Digital Data Flow Overview
- Digital Data Flow Frequently Asked Questions
- Digital Data Flow Webinars & Videos