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General updates: We’re making good progress on v2 development - Roughly 80% of the planned functionality is complete. You can see our progress here. The v2 subteam is meeting twice a month, and everyone is getting up to speed quickly. We’re planning to begin an internal alpha testing process in Q1 2021.
All about those charts:
Xiao Ni gave the team an overview of safety charts development proposals. See slides here
Action item for the team: Everyone to review the slides and think about safety questions that needs to be answered & to propose ways (charts/tables) that can help to answer these questions. These would help the team to form concrete next-step plans in the new year.
Xuelong asked a question about access issues for different individuals due to their read/access privileges, Can R studio or the app take over firewall permission? Jeremy suggested that things might be easier in V2.0, and in general, there might be other ways to help in those situations, for example, to process data upfront before feed into the app. Xuelong also asked how to make things easier for the end users, such as safety clinicians, who seems to be very interested. Xuelong to follow up with Jeremy offline for a more detailed conversation.
2. TIRS paper updates
Jim shared with the team that back in 2019 after Jim and Susan did a presentation at DIA, a TIRS editor approached to him suggesting a manuscript describing the team’s effort. The manuscript is now ready for the entire team’s review and feedback. Everyone will be listed in the acknowledgement section to recognize everyone’s contribution to the joint effort. If anyone is motivated to contribute text to the paper, we’d welcome that too and elevate you to the authorship line.
Post meeting note: Jim has sent out the draft manuscript to everyone.
Mengchun introduced that the next safety topic we might be able to work on is QT prolongation. The team was able to touch base with Richard Anziano, who is the author of a famous ECG graphic on CTSpedia (see link here . Rich expressed his interested to join the team’s efforts, in one way or another. Will keep the team posted on the progress.
4. Upcoming presentation at 22nd pharmacovigilance 2020 virtual meeting
Jim shared with the team that Bill was initially invited to present at the upcoming 22nd pharmacovigilance 2020 virtual meeting (Dec 10), which is also a very important meeting in the safety world. Bill extended the invite to us to speak aggregated safety evaluation, from natural intelligence to intelligence augmentation. The presentation will talk from planning process (ASAP, BRAP) to leveraging tools (ISG, BRATS). This is truly a great recognition of the taskforce and the working group to give this presentation.
5. All-hands meeting (Dec 18, 2020)
Mengchun shared with the team that Jim has been officially named as one of the three co-chairs of the working group, overseeing all the activities across all the three workstream. Congratulations Jim!!
There is one more all-hands meeting for the entire working group this year on Dec 18, 2020, everyone is encouraged to join the meeting so to get to know what is going on outside of the taskforce. Anyone who does not have the invitation on your calendar (Dec 18, 2020 at 12PM EST) can reach out to Mengchun. Joining this all-hands meeting is also not mandatory.
Action items:
Everyone to review the slides Xiao prepared and think about safety questions that needs to be answered & to propose ways (charts/tables) that can help to answer these questions. These would help the team to form concrete next-step plans in the new year.
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Meeting Minutes
Date And Time
Dec 2, 2020
1PM-2PM EST
Attendees
Topics and Notes
1. Technical updates V2.0
Xiao Ni gave the team an overview of safety charts development proposals. See slides here
2. TIRS paper updates
3. ECG graphics: potential collaboration opportunity
4. Upcoming presentation at 22nd pharmacovigilance 2020 virtual meeting
5. All-hands meeting (Dec 18, 2020)
Action items:
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