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Actions from kick off meetings

  • Mike - Needs to request FDA participation in the POC project
  • All - Option 1 real filing POC project, call for sponsors to participate
  • Real filing POC option 2 and 3 to discuss in next meeting

Discussion Interactive analysis questions

  • Hope to develop a recommendation at industry level with input from FDA
  • What is a feasible framework to share data and results in interactive fashion
  • Confidentiality issue with real filing POC what are the rules and responsibilities between FDA and PhUSE?
  • Addressing the Logistics for filing
  • PhUSE support the project team with the process and connecting the project with the FDA

Interactive analysis a paradigm shift

  • Avoid discrepancies by providing visualisations of the analysis results data set that was used in the SCR
  • Eric- FDA is doing interactive analysis with JReview but defining what were the filtering conditions and what flags were being used (Sharing and exporting definitions that they use with the FDA will help speed up the process)
  • Paul - JReview and jump clinical are only done by clinicians
  • FDA want to share data to be able to assess data quality
  • Paul (FDA) - Jannet Woodcock wants to revise some of the current practices for reviews and come up with an inter-disciplinary review process which may pull clinicians out of the reviewing data
  • Interactive tools can be useful for exploratory analysis the problem is if you have pre-specified in points
  • Paul- Very few Clinicians can write their own code so they are using the interactive analysis tools
  • Paul- Very few people would feel comfortable signing off a drug that was reviewed purely through interactive tools they want to ensure that the analysis is protocol which means checking their own script
  • Zack- If we are going to provide a visualisation tool for submission it would have to include the pre-specified analysis the sponsor would have to provide those results we can provide pre-specified analysis and allow exploration.
  • Safety is the main priority
  • What does traceability and translucency look like for interactive tools?
  • Paul - Internal Shiny user script that is very active (Share with the group next meeting if approved by supervisor)