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HTT update 20210726

25 August 2021 Update

26 July 2021 Update

We are pleased to announce some recent accomplishments of the High-throughput truthing project (HTT).

The HTT project’s objective is to create a validation dataset fit for a regulatory purpose. Pursuing this objective is expected to inform regulatory frameworks and be instructive to others to develop their own validation datasets. For more detailed information about the project and/or to register as a pathologist-data-collector, please visit https://ncihub.org/groups/eedapstudies/.

Please contact Katherine Elfer (Katherine.Elfer@fda.hhs.gov), Project Coordinator, or Brandon Gallas (Brandon.Gallas@fda.hhs.gov), Project Lead, with any questions or to join our efforts.

Upcoming activities

9/3/2021: Discussion about patient sampling for HTT pivotal study and CME Training

  • Lead: Victor Garcia, MD, is a new FDA fellow, board certified in internal medicine and recently completed a Clinical Informatics Fellowship.

Summer 2021-Fall 2021: Recruiting Pathologists for on-site Data Collection

Recent accomplishments

8/19/2021: FDA Summer Intern Festival – Google Summer of Code Video

  • 2021 Google Summer of Code Intern Peddi Sai Varshith recorded a video of his work with the High Truthing Project and integrating hardware with caMicroscope
  • Video and Project Summary: HERE

8/12/2021: FDA Annual Summer Student Scientific Poster Day

  • 9:30 – 11:30am EDT
  • Two Posters from our summer interns:

8/8/2021: Public Release of the HTT !Github Repository

  • Contains primary data objects (with documentation) and supporting functions
  • Contains Pathology Informatics R markdown file with code to process data and create all figures
  • Repository: https://github.com/DIDSR/HTT

8/8/2021: Presentation at the American Statistical Society Joint Statistical Meetings

  • “Pathologist Agreement from Quantitative Measurements: a Pilot Study”
  • In coordination with this presentation and the corresponding proceedings paper, we intend to make public a GitHub repository (name “HTT”) with an R data package containing the pathologist annotations.
  • LINK to Full Recordings and Abstract
  • LINK to Conference Program

7/2021: Statistical Methods Presentation

  • Si Wen, Statistician FDA/CDRH/OSEL/Division of Imaging, Diagnostics, and Software Reliability
  • Title: Quantitative Agreement Analysis for HTT Pilot Study Data
  • Watch HERE
  • GitHub repository with methods: https://github.com/DIDSR/ANOVA.MRMC.LOA
  • Related manuscript: Preprint on arXiv – 2107.08891. It has been submitted to Statistics in Biopharmaceutical Research.

7/2021: Shipped eeDAP system to Yale for microscope-mode data collection

  • eeDAP Github Repo
  • Microscope professionally cleaned and ready for data collection
  • Looking for pathologists to provide annotations
  • Upgraded eeDAP hardware for speed
  • Resolved third-party software version conflicts (Bioformats, Java, and Matlab – https://github.com/DIDSR/eeDAP/issues/89 )

7/2021: We have executed two research collaboration agreements (RCA) for slide sourcing.

6/2021: Hired five summer research assistants to support related research

  • Victor Garcia, MD MS: Stony Brook Medicine
  • Sarah Dudgeon, MPH (back to join us for data collection!): CORE Center for Computational Health New Haven Hospital
  • John Paul (JP) Philips: University of Chicago, Dept. of Physics
  • Phoebe Qian: Mc.Clean High School, VA
  • James Setty: Wall High School, D.C.

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