High-Throughput Truthing Year 3
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| 1 | ===Year 3: High-throughput truthing of microscope slides to validate artificial intelligence algorithms analyzing digital scans of pathology slides: data collection to create the medical device development tool (MDDT)=== | |||
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| 3 | In Year 3 of the High Throughput Truthing project, the team will collect data at various collaborating sites and conferences. [[BR]] | |||
| 4 | Check out our completed work from [HighThroughputTruthingYear1 Year 1] and [HighThroughputTruthingYear2 Year 2] in the HTT project [[BR]] | |||
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| 6 | * [https://ncihub.org/groups/eedapstudies/wiki/HTTdataCollectionTraining/File:20200928_HTT_recruitPathologists-v1.pdf Link to pathologist recruiting advertisement] | |||
| 7 | * Research collaboration agreement scope for collaborators providing slides and other materials | |||
| 8 | - | * [[ |
+ | * [[File(CDRH_RCA_Gallas_Template_7-23-2020.doc)]]
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| 10 | '''Pitch:''':: | |||
| 11 | We are crowdsourcing pathologists to collect data (images + pathologist annotations) that can be qualified by the FDA/CDRH medical device development tool program (MDDT). If successful, the MDDT qualified data along with a statistical software package for data analysis would be available to any algorithm developer to be used to validate their algorithm performance in a submission to the FDA/CDRH. | |||
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| 14 | Researchers from the U.S. Food and Drug Administration, alongside academic collaborators, are collecting pathologist annotations as data for AI/ML algorithm validation for tumor infiltrating lymphocyte (TIL) detection and quantitation. We are asking board-certified anatomic pathologists and anatomic pathology residents to score 80 ROIs as part of a research study. We anticipate that this task will take participants a total of 30 minutes. The data are intended to inform the agency’s approach to novel algorithm validation, ensuring high quality commercial products with a faster FDA-pipeline to approval. [[BR]] [[BR]] | |||
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| 16 | ===[HTTdataCollectionTraining Complete the HTT Data Collection Training]=== | |||
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| 19 | __Consent Form:__ [[BR]] | |||
| 20 | [[File(HTT_IRBinformedConsent.pdf)]] | |||
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| 22 | ===[HTTstartDataCollection Begin Data Collection]=== | |||
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| 24 | __Exit Survey:__ [[BR]] | |||
| 25 | Please complete [https://docs.google.com/forms/d/e/1FAIpQLScRhtEN7cudrG3-0eauke1Dg_9JySpANK0mj3dRqk7c15WN6w/viewform this Survey] when you finish data collection, and help us improve the HTT project. | |||
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| 27 | __Get Involved:__ [[BR]] | |||
| 28 | * Supply glass slides and their scanned versions | |||
| 29 | * Help create a Continuing Medical Education course in conjunction with this project | |||
| 30 | * Host an analog (microscope + eeDAP) data collection event at your clinical site | |||
| 31 | * Help spread the word, recruit your colleagues to participate in online data collection | |||
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| 33 | __Thank you. For more information contact:__ [[BR]] | |||
| 34 | '''Brandon Gallas''', !PhD, ([mailto:brandon.gallas@fda.hhs.gov brandon.gallas@fda.hhs.gov]) [[BR]] | |||
| 35 | FDA/CDRH/OSEL Division of Imaging, Diagnostics, and Software Reliability [[BR]] | |||
| 36 | on behalf of the High-Throughput Truthing (HTT) Project | |||