Jul 2021 full team meeting minutes (core team meeting minutes are embedded)

[mli1]

• Opening side talk:
o Zak will demo hepatic explorer to EMA to show the feasibility of including interactive visualizations in submissions. Jim shared the recent updates to hepexplorer including PAlt and nR ratio (live example page).
• Alpha testing
o Jeremy provided a summary of the recent alpha testing. Six technical contributors participated and successfully completed the testing. Several issues were identified and fixed. The testing discussion is captured in this thread #538
• Beta testing
o Jeremy updated the team on the V2 beta testing plan #592 and called for volunteers to contribute to the beta testing preparation
o Timing: due to several key pending issues, the beta testing is expected to start in Fall 2021
o In the context of supporting V2 launch Susan initiated an excellent discussion on broader successful adoption / support of the ISG tools by the industry and FDA
 Susan complimented on the community effort and contributions and raised the question on attracting more hands-on tech contributors for sustained development
 Zak commented that “non-validated” status might be perceived as a hurdle for organizations to adopt
 Xiao asked if the FDA’s acknowledge of the tool could lead to broader adoption by industry
 Susan: it is difficult for FDA to endorse software due to constraints
 Skip echoed Susan’s comment but offered engagement. Skip is looking for hiring an analyst to contribute to ISG
 Jeremy provided his recommendation: roll out V2, and put effort in “validation” for more production use.
 Zak agreed to provide updates in future meetings on the PhUSE interactive HTML submission work
• Forest plot PhUSE/ISG collaboration
o Melvin, Maya and Jeremy successfully delivered the aesummaries pkg, congratulations!
o Melvin gave a background and history of this tool
o Maya demoed the main functionalities of forest plot for AE comparison statistics such as risk difference
o Jeremy clarified this tool uses analysis result data, whereas safetyGraphics uses patient level data
o Jeremy is considering including aesummaries forest plot in the upcoming V2 release

(Thank you Xiao for taking the notes)

Action item:
1- To generate a list of FDA colleagues who were involved in V1.0 beta testing (to be done prior to beta testing)
2- To generate a list of companies to be involved in V2.0 beta testing (to be done prior to beta testing)--- also asking for volunteers
3- Github tracking (saved for future discussion)