Discussion about patient sampling for HTT pivotal study
* Lead: Victor Garcia is a new FDA fellow with an MD and a Clinical Informatics Fellowship.
* Contact Katherine Elfer or Brandon Gallas to join the conversation
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 with an R data package containing the pathologist annotations.
* [Presentation:JSMPathologistAgreementfromQuantitativeMeasurements:aPilotStudy LINK to Full Presentation Information
8/12/2021: FDA Annual Summer Student Scientific Poster Day
9:30 – 11:30am EDT
Two Posters from our summer interns:
Title 1: Developing a controlled workflow for clinical studies to collect pathologist annotations
Title 2: Communication Methods and Workflows to Develop and Implement High Throughput Truthing of Pathologist Annotations as a Reference Standard for Validating Artificial Intelligence in Digital Pathology.
Link to full abstracts
Link to Register for full FDA Webcast & Poster Event
Summer 2021-Fall 2021: Recruiting Pathologists for on-site Data Collection
We are looking for pathologists to provide annotations using the eeDAP system
Data Collection Sites; Yale New Haven Land Stony Brook Medicine (early Fall 2021)
LINK to full recruitment and information
Recent accomplishments
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
Presentation video and GitHub repo with methods coming and will be linked HERE
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
7/2021: We have executed two research collaboration agreements (RCA) for slide sourcing.
6/2021: Hired six summer research assistants to support related research
Created on 26 Jul 2021 , Last modified on 26 Jul 2021
