March 27th 2018 Minutes

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Attendees: Eric, Bharath, Elena, Hari, Heather, Karl, Pascale, Mike, Mellisa, Catherine, Zak, Ingeborg, Srinivas, Susan Duke, Gaoyang Li

Apologies: Josephine, Paul, Sharon


  • Welcome new member Catherine
    • Part of OCS/FDA
    • Background in software and in computational mathematics
  • Karl - Working within analytics domain working with R and Python
    • Now works within statistical programming
  • Gaoyang Li - Bayer - Works in Clinical Trials

Updates from sub groups
Best Practices for Interactive Analyses

    • Made good connections with Susan Duke and Karl brand at CSS
    • Looking to standardise our API when we do submissions
    • Solution would not be comfortable with how things are at the FDA the solution would be for a third party to hold

Use of Data Visualisation for Subject Level Data Review

    • Presented a poster at CSS
    • Plans are to develop the poster into a white paper that will include images of the tools
    • Another white paper will be produced on the features that people want in the tools as a help to people who are developing these tools
    • Also met with Susan Duke work within the DIA group could help with all DV projects
    • ASA and DIA team are doing have a lot of connectivity with Subject Level Data Review
    • Any Rshiny or Java experts? to work within this group
    • Zak - It is possible to design the tool to guide the user

Use of Data Visualisation for Data Anomaly Detection

    • Working on Data Anomaly Detection with DV
    • Goal to organise speaker presentations (List has been identified)
    • AZ may be added to the speaker list
    • Any other presenters interested please reach out to Heather
    • Summary and White paper discussion gaps in future product innovation recommend specific areas to focus on

  • Follow up from CSS
  • Opportunities for collaborations/presentations
  • AI - Kevin Lee to attend one of the meetings to share what the team are working on
  • ASA - Susan (representative) to give an overview of what the team are working on
  • Data Transparency - Potential project on Narratives which is focused on transparency within narratives this may have correlation with sub team 2 (subject level data review)
  • FDA
  • Data Integrity Advisory Board
  • Clinical Endpoints working group
  • PK/PD Data Anomaly Working Group (DAWG)
  • US Connect DV presentations Preview

  • Open Discussion
  • Gaoyang Li - Look into analyses of clinical trial data does anyone have any experience with Tablo?
  • Zaks group sometimes uses Tablo


  • Susan to potentially give a talk on graphical perception
  • Mike and Mellisa to pull together to see if there are any topics we can put together for collaborations
  • All to look at the connect meeting topics (data analytics) may be something we'd like to tap into