July 11th 2018 Minutes

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Attendees: Bharath,Eric, Dragomir, Gaoyang, Hair, Ingeborg, Karl, Karnika, Zak, Eunice, Steve, Eunice, Rink, Susan,

Apologies: Arlene, Bhaskar, Sharon, Ashish

Agenda:

Sub-team updates

Best Practices for Interactive Analyses Decision Making and Submission

  • Moving forward with making proposals to the FDA to support software we could use to deliver the prototype to the FDA
  • There is some renewed interest in Lilly to do a pilot study
  • Before we pick a submission we'd like to test the technology first and do something with fake data to see if FDA can access this
  • Platform and software - Strong urge to use spotfire within Lilly
    • Steve - Spotfire was a non starter for us as we do not have the licensing, this is something which would not be shareable with the FDA
    • What if you were given a licence? and the web player access was free allowing you to interact, this was not highlighted previously
    • Open source is desirable within the FDA
    • Rshiny was well accepted by FDA
    • Would like to do a pilot study to make this white paper relevant
    • How do we get an IP and third party to support it
    • Rinki - Merck - We did a small pilot with Rshiny and created an AP app
    • Rinki will look to give a presentation on this to the team


Use of Data Visualisation for Subject Level Data Review

  • Working on the survey questions to get the clearest answer we can get
  • We are meeting tomorrow to discuss the survey results and depending on the feedback we could have it out to get answers and turn it round to be presented in November
  • We are hoping to open the survey in August


Use of Data Visualisation for Data Anomaly Detection

  • Speaker meetings will be sent out to the DV team
  • We have a solid list of speakers


AOB

  • EU Connect - Frankfurt - Early Bird reg closes July 27th


Actions

  • Rinki - Will look to organise a meeting with sub team 1 to give a talk on their pilot