Faro Health’s Post

Something that, I think, will be of interest to those following the TransCelerate BioPharma Inc. and CDISC Digitial Data Flow (DDF) and the Unified Study Definitions Model (USDM) work. A few weeks back there was an excellent "DDF in Action" day held by TransCelerate and hosted jointly at J&J in New Jersey and at Novo Nordisk in Copenhagen. I was asked to do the usual "introduction to USDM" talk and just fancied doing something a little different, so I did a single "infographic" / slide. The slide starts to paint a picture of all the use cases where a "digital protocol" might impact the development lifecycle. If this was a jigsaw puzzle, this is the corners and the edge pieces, the obvious use cases. There are many more, the great bulk of the picture in the middle of the jigsaw, the list is not exhaustive by any means. The good thing, it might be a bad thing, we are not sure what picture will emerge when we complete the jigsaw. However, we have the opportunity to shape that picture. One thing I pointed out when presenting this is we, as an industry, love putting things into buckets, we love to categorise stuff. Across the top in blue are what most people consider the main areas in the lifecycle. But I noted during the talk that this will become much more of a continuum, multiple roles adding increasing detail to a study definition that incorporates the protocol (and allow for it to be rendered) but will also provide so much more. What would be wonderful is if the community could give me more use cases ... nothing like a bit of crowd sourcing. Just add any to the comments below. One comment I often make is that there is a use case any time we pick up that protocol PDF and transcribe some information from it, dare I say it, into Excel 😀 One note, the retrospective versus prospective bar across the top. Retrospective is digitising old protocols to inform the writing of new protocols. Prospective is the development of a new protocol and its subsequent use within a study. Any comments / thoughts most welcome.

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CDISC invites you to submit comments on the draft v3.0 of the Unified Study Definitions Model (USDM) during the 30-day Public Review period. CDISC, in continued collaboration with TransCelerate BioPharma Inc.’s Digital Data Flow Project, is updating the reference architecture, which will serve as a standard model for the development of a Study Definitions Repository. The Repository is a novel central component aimed at facilitating the exchange of structured study definitions across clinical systems using technical and data standards. The focus of Phase 3 is: • Representation of draft ICH M11 CeSHarP (Clinical electronic Structured Harmonised Protocol) elements in USDM • Addition of elements to the USDM to demonstrate automated population of selected SDTM Trial Design datasets • Addition of elements to the USDM to demonstrate automated population of selected Clinical Trial Registry fields • Updates to the USDM to cater for more Complex Studies/Cohort Studies USDM Model Enhancements • Deliverables include a logical data model, supporting Controlled Terminology, API specifications, and an associated Implementation Guide. To Provide Comments: An information page on the draft USDM v3.0 for public review can be here. https://lnkd.in/erQ8-uRt Public Review closes 22 Feb 2024

“I spent $11M to create this database. Will my data be analyzed the best way?”This is the 3rd time I am asked this question. The 1st time, I was an assistant professor in Duke. Eventually the clinician scientist and I developed a precision prognosis tool for Osteoarthritis (OA) on RWD. It’s published, patented, and validated in Pfizer, AbbVie studies, and marketed by a CRO. It’s used for enriching fast-progressers for OA trials patient enrollment; The 2nd time, I was a statistician in AbbVie. Combining phase 2 trial data and RWD, the lead clinician and I were able to advise company a “go/no-go” decion towards a Phase 3. The sandbox simulation approach won an AbbVie award and was presented in plenary sessions of several top scientific conferences; The 3rd time, the situation is different. CROs are known for SOPs, excellent in programmed-delivery, following predefined contracts. So, for this $11M RWD, if the “best analysis“ happens to be predefined in the contract, then, sure, your baby will be in a pair of good hands. But, if we don’t know what the best analysis is before seeing the data(so called data driven), then let’s sit down and discuss a better way of collaborating, partner vs vendor. A spearhead team is desirable, for “best analysis”

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The need to digitize clinical protocols in order to streamline clinical trials and enhance data exchange is paramount, as highlighted in this article. The Digital Data Flow (DDF) initiative, developed collaboratively by TransCelerate BioPharma and CDISC, has birthed the Unified Study Definitions Model (USDM), which enables machine-readable protocol information and seamless system exchanges. Leaders in healthcare and biopharma are encouraged to showcase the value of protocol digitization, map out a plan for IT system conformity, and ready themselves for key human and procedural adjustments.   #ClinicalProtocol DigitalDataFlow