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Michael G. Kurilla M.D., Ph.D.

NCATS Director of Clinical Innovation

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Annual CTSA Program Meeting Recap

By: Michael Kurilla, M.D., Ph.D., NCATS Director of the Division of Clinical Innovation

December 5, 2023

Before heading into the holiday season in earnest, a recap of the CTSA Fall Program meeting is in order. This year’s meeting was held 11/6-8 here in DC metro area with over 400 participants in attendance, making for intense and engaging discussions on Leveraging Real World Data (RWD) and Artificial Intelligence (AI) to Advance Translation. The Steering Committee met on Monday with the central topic focused on the progress of the Real World Data (RWD) Taskforce with an emphasis on ‘what the hubs need?’ The original charge was to better understand the technology environment they need to be productive in using RWD. As the Taskforce’s work got underway, it became clear that more fundamental questions needed to be addressed. For example, one recognized barrier is a lack of both a common terminology as well as basic understanding of processes and resources in this space. To meet this need, a crowdsourced glossary is in development and identification of training needs is in the works. As the Taskforce’s work has continued, their focus has shifted to characterizing the breadth and scope of potential clinical and translational research activities for the consortium to tackle, to consideration of breaking more than just speed barriers, to identifying necessary infrastructure and resources, and not ignoring training requirements as the group. The next steps will be working with Hubs and to identify opportunities for the CTSA Program to be a leader in RWD research.


On Tuesday Renee Wegrzyn and Andrea Bild from ARPA-H provided the keynote to open the meeting. While Renee spoke about several ‘darpaesque’ projects (such as tissue regeneration for osteoarthritis), it was Andrea’s discussion of both the Biomedical Data Fabric (BDF) and Advancing Clinical Trials Readiness (ACTR) programs that captured the interest of the audience. Both of these projects are still too inchoate to offer specific details, but NCATS is actively engaged in discussions with ARPA-H and we hope to provide updates in the new year.
 

The next session considered decentralized clinical trials with a variety of perspectives, including the FDA viewpoint as well as a statistician from West Point. The TIN also participated and offered an overview of a wide assortment of resources available to the CTSA community to support decentralized trials. After lunch, the next session was focused on artificial intelligence (AI). A variety of perspectives were offered including two participants from the private sector. Data quality and potential bias were highlighted as critical issues to address early. The last session of the day was focused on training. Leading was a representative from the NCATS Education group, outlining the essential attributes of translational science. Subsequent speakers discussed training aspects along the translational science spectrum with reference to the highlighted translational science attributes.


Tuesday evening was devoted to the poster session with much lucubration throughout the evening.


Wednesday morning led with a session on RWD that covered training aspects as well as responsible AI with strategies to mitigate bias. This was followed by a series of breakouts where more detailed, smaller group discussions on subtopics could be entertained. Finally, the last session was devoted to presentations from several hubs describing either successful RC2 applications or the Element E components of their UM1 applications. Rounding out the meeting Duane and I announced the poster session awardees and honorable mentions and offered ten takeaways.


Slides and recordings for the meeting will be deposited on the CCOS website in early December.


Happy holidays to everyone and looking forward to seeing everyone in the new year.
 

“ART said, "I want an apology."
I made an obscene gesture at the ceiling with both hands.
(I know ART isn't the ceiling, but the humans kept looking up there like it was.)
ART said, "That was unnecessary."
In a low voice, Ratthi commented to Overse, "Anyone who thinks machine intelligences 
don't have emotions needs to be in this very uncomfortable room right now.”

- Martha Wells, Network Effect 

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