ICH M11 enables a fully autogenerated digital clinical protocol; are we future ready?

by Jun 7, 2024

Michael Penlington
Director, Digital Clinical Development Solutions

ICH M11 enables a fully autogenerated digital clinical protocol; are we future ready?

I The ICH M11 initiative is a significant stride in the journey to develop a fully digital protocol. In part because, being ICH, there is significant regulatory influence. We have seen that regulatory authority-led initiatives, such as the FDAAA 2007, change behaviours and culture. But ICH M11 goes beyond just a protocol template and guideline. The accompanying technical specifications outline the data elements, their attributes and relationships, and conformance for the electronic exchange of protocol content. Each technical specification represents an independent, data-extractable element in the protocol, building the foundation for a consistent data exchange format that regulatory authorities will accept.

I The technical specifications can be aligned with the CDISC Unified Study Definition Model (USDM), which is already highly standardized, or digitalized as other elements of study design (eg, endpoints, eligibility criteria, blinding).

I Now, at last, we can imagine a world where clinical study protocols evolve into autogenerated artifacts of digitalized study definitions. Downstream activities can be driven by these definitions, independent of the protocol itself. Cycle times shorten. Furthermore, as protocol technical specifications become more standardized, so too will study methodologies, enhancing the comparability of clinical trial results. This, in turn, could lead to better insights into study designs that truly benefit patients. While this may seem like a distant goal, time is pressing. Sign-off and adoption of this ICH M11 package are targeted towards the end of next year, with the Technical Implementation Guide for Fast Healthcare Interoperability Resources to be finalized by mid-2026. Excitingly, the technology to generate digital protocols from study definitions/technical specifications is already available, making it a very attainable future.

For more on how we can support the upcoming ICH M11 protocol specifications, check out Frederik’s blog https://www.linkedin.com/posts/nurocor_reflections-on-the-nurocor-journey-nurocor-activity-7197259817365741568-wWlg?utm_source=share&utm_medium=member_desktop

#clinicaltrials #digitalinnovation #automation #digitalhealth #clinicaldevelopment #digitalization