eeDAP studies: update objectives and next steps
I hope you were wondering why I haven’t communicated in a while… Besides my day job getting in the way, I have been having one-to-one T-cons and trying to find out what everyone’s goals are for this collaboration. While I am happy that everyone on the original email still wants to be involved, “statements” of objectives are still in development. You can find the current status at https://nciphub.org/groups/eedapstudies/wiki. See how I listed your team and update as you see fit.
In addition to my team (which essentially includes my NCI colleagues), we have two teams with statements that show a strong commitment to moving forward (MSKCC and Inspirata), two teams with statements in the works (Leeds and Philips), and two teams with less formal statements (IIT and CSHL). I never expected every team to be involved to the same degree or pace, and I am not asking for any promises. I think we will have plenty to talk about as the three “ready” teams move forward. I just hope that everyone will at least be a part of the discussions to come.
Speaking of discussions. It’s time for a T-con. I will send a poll to set a date. Please respond to this quickly so that we can get it on the calendar. After quick introductions, I hope we can start discussing plans for the three ready groups.
Lastly, here is an update from FDA
- We have not yet heard from FDA regarding the MDDT proposal we submitted at the end of Jan. We were told that a response would come within 30 days.
- We have prepared a pilot study and will give it a test run on Monday, mostly to evaluate how long it takes to evaluate about 1/4 a high powered FOV on the microscope and the WSI.
- We have conducted a mitotic counting study and have been analyzing the data. There is some survival data and the counts were collected in several modes (2 stains on the microscope and WSI). The analyses can be grouped into two types: performance (agreement with survival: Harrell’s C, AUC, Sensitivity, and Specificity) and agreement (intra- or inter-reader AND intra- or inter-modality). I want to share the results with the group, learn what other analyses should be considered, come to some consensus on how to summarize this kind of data, and build templates and software to produce standardized reports.
- We have secured space and time to hold a meeting Sunday afternoon right before Pathology Informatics (May 21, http://www.pathologyinformatics.com/). We hope to report on the work above and the MDDT progress. We hope that you will attend and participate by discussing your eeDAP study protocol, development, pilot, plans (whatever stage you are at and topic you want to discuss).
- We have added a new feature to eeDAP where we can open specific FOVs in ImageScope so that the study pathologist can use that as the viewing software while entering their evaluations into the Matlab eeDAP GUI. In other words, eeDAP can now drive ImageScope just as it can control the microscope stage. Viewing the images in built-for-WSI viewers is a much better experience for the study pathologist (esp. pan and zoom) and can obviate the need for color calibration of the Matlab eeDAP image presentation. We hope to support other viewers. In fact, we have started work on OMERO, as it supports many image formats, and it is free and available under the GNU General public license. We would enjoy working with any of you to extend eeDAP to control other viewers.
In closing, I would like to move all communications to https://nciphub.org/groups/eedapstudies and out of my email box. That way I can consolidate, archive, and ultimately share this work. For example, this email, the previous email, and all future emails can be found at https://nciphub.org/groups/eedapstudies/blog. While a representative from each group has joined this collaboration space, others will miss messages to that space. Please join. Please note that the group is currently open to the public, but we may make the group private in the early goings if needed. Discussions there and with me generally, are expected to be ultimately shared with the community.
All the best,
Brandon D. Gallas, PhD
Center For Devices and Radiological Health
Office of Science and Engineering Laboratories
U.S. Food and Drug Administration
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