Mar 2021 Full Team Meeting

[mli1]

Attendees

@JimBuchanan @xni7 @hendricksonb @DOBrien1 @mli1 @anzianorj @MayaGans @PHayashi @spduke @MelvinSMunsaka Bo Wang, Veronica Pei, Greg Ball, Gabrielle Murashova, Nileshkumar Patel, Siu-Chi Sun, Scott Wong, Yu-Yi Hsu, Claire Ji... ( I think I have missed someone here??)

Agenda/Notes

1. Welcome new members: Siu-Chi Sun, Scott Wong, Yu-Yi Hsu, Claire Ji, Jonathan Seltzer
2. Congratulations to Jeremy!! Welcome baby Adela!
3. Progress on collecting safety questions
   o The priority for ISG is to get platform V2.0 ready. Tech team will be busy through Q2 2021.
   o At the meanwhile, clinicians and some statisticians are not involved in the effort above. For these team members, we have QT and AE volcano plot two topics that we can work on to think of what to do in the future.
   * QT topic and update. A subgroup meeting was held in early Mar. It was decided to work closely with the Cardiac Safety Research Consortium (CSRC), starting with QT prolongation topic. It turned out Jonathan Seltzer (already a member of the working group) is the Executive Director of CSRC. An introductory meeting is to be scheduled between ISG and CSRC in late Mar/early Apr. With the expertise from CSRC, and their new research on several physiological biomarkers, ISG will be able not only to develop interactive tools on QT data, but also to include other cutting-edge biomarkers or parameters into the tool. Also very importantly, Yu-Yi and Claire joined ISG from FDA QT group (thanks to Veronica!!). Rich Anziano @anzianorj , who is the author of the CTSpedia QT graphics, is also in the taskforce and we will start with his QT graphics and make it into an interactive version.
   * AE volcano plot and update. AE volcano plot V1.0 prototype is almost done. Brian @DOBrien1 has developed a draft version of the clinical workflow. Now asking for volunteers, especially statisticians to work with him on the workflow. Xiao @xni7, Asli and Scott volunteered to work with Dennis on this. There are also future features to be added as enhancement. These included other safety questions such as AE Vs onset timing, AE Vs exposure data or different dose group, AE Vs con-med, etc. Some features such as KM plot, can be added as V2.0. Team is encouraged to share thoughts on the safety questions (and if applicable, possible suggested charts)
   * Susan @spduke suggested that we should consider a "launch team" to plan ahead of time so we can effectively introduce the deliverables to broader community (including IT and the actual user community). Team agreed that this will be very important aspect, as important as the good science and good technology itself. Some venues including presentation, publication, social media such as Youtube and Linkedin. Mengchun will assign this as a new subgroup and will bring it back after some thinking by the core team.
   4- Again, encourage team to continue adding comments to the safety question, and safety chart specs
   5- Greg Ball to speak to collaboration with PhUSE. The starting point is now identified as "validation process, what can we learn from PhUSE's experience and how we can work with them to validate our tool". Greg is also planning to bring different groups together to minimize duplicated work and try to find synergy among different working groups. A meeting is in planning.
   6- Encourage team to continue to work on the security document.
   7- Apr 2021 virtual team building
   o Things to be prepared by each individual: everyone to prepare 2 facts and 1 lie about yourself, and 1 or 2 pictures. Team will be divided into small groups, in which everyone will get a chance to share the facts and lie and ask team members to guess which is the lie. For the picture, each member to share the story behind it, or why it is important. Small groups will then gather together by sharing some highlights from each group.

Action Items

• @mli1 to schedule meeting with CSRC (with Jonathan), and other FU discussions with QT subgroup
• @xni7 Asli, and Scott to work with @DOBrien1 on AE volcano plot clinical workflow
• @mli1 to bring the "launch team" subgroup idea to core team for more thinking and planning, and bring it back to full team meeting
• Greg Ball to schedule meeting with other working groups within the Safety Graphics Universe for synergy
• Full team to prepare for the upcoming Virtual team building (2 facts, 1 lie and some pictures)
• New members to register on GitHub and core team to send invites to new members