- Recap the install at MSKCC and discuss summer plans.
- Brandon summarized the MSKCC visit: Install eeDAP, train key readers, and practice data collection.
- At first, the registration process seemed too onerous for some participants. After sitting at the system, participants were successful with the registration process and became more comfortable and confident. The MSKCC participants should be applauded for their patience and committment.
- Registration requires a trained person to complete and does take time (3 min/slide). MSKCC identified two research fellows that will be responsible for registering the slides before each study (microscope mode).
- There were a few documents created to coordinate the readers and help conduct the study: informed consent form for participating pathologists, a form to collect pathologist information and specify that pathologists task list, a cheat sheet for conducting the study, and a definition of a mitosis for use in the study. These documents can be found here.
- Yukako shared that the day went very well. She said that the different participants echoed excitement about the technology, as is evidenced by the pathology fellows that are volunteering to be the study administrators (perform the registration process and assist with data collection).
- The eeDAP system is in a sign-out room where other pathologists in the department are able to see the system. They are asking questions and some are volunteering to participate. We will get more than the 3-5 that we planned for (not counting any CSHL pathologists that will participate).
- They are meeting this week to reinforce the training and make sure all are ready to begin.
- We are developing an MTA for the equipment.
- Once the MTA is in place, we will develop an RCA to govern the data collection. Basic elements are that we will collect and share data, publish and keep each other informed on publication plans, and then put the data in the public domain.
- Lastly, Brandon discussed that he will update the “context of use” of the eeDAP MDDT to be based on the technical abilities and performance. The update will also have more details on the registration accuracy and the image display. The plan is to circulate something with this group near the end of the month and then engage the FDA on the next steps.