SS P08 17March2015 Standard Scripts Project 08 Meeting

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Meeting Record

When: 17 March 2015 (White Paper Project Breakout session at CSS)
Place: Silver Spring, MD
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: (Did not write the attendees down - going by sign-up sheet) Sascha, Asa, Terry, Mercy, Wei, Frank, Karolyn, Kristen, Nhi, Gustav, Mithun, Julie, Jim, Karin, Steve

  1. Hepatotoxicity White Paper
  2. Adverse Events White Paper
  3. Questionnaire White Paper


  • Hepatotoxicity White Paper
    • Agreement that time to event and duration for lab-collected data is less useful as these are "scheduled" not true times/durations as with AEs
    • Nhi went over the types of things she looks at - AST/ALT rise; ALT/Alk phos (R value) - <5 of interest. FDA uses eDISH software which focuses on Hy's range cases.
    • Need more discussion on not having total bili (in text)
    • Discussed whether hepatic should have own ADaM (ADHY vs ADLB) - leanding toward own?
    • Need more discussion on if and how to include CTCAE grades (text only)?
    • Nhi focuses on ALT>3 and Alk phos <2 within 30 day window. If R >5 probably not hepatocellular (need to confirm my notes on this)
    • We should look at the book chapter on hepatic (need to get this reference and send to group)
    • When this white paper is ready for review, Nhi can ask Bob Temple for review
    • Discussed individual display - Figure for sure, probably don't need a corresponding listing, Need treatment, demographics, etc. info at top of figure.
  • Adverse Events white paper
    • Some things required for CT Registry; Terry mentioned there's a EU standard where some things might be required
    • We should get a copy of the Clinical Review Template if sharable
    • Discussed exposure-adjusted - Most do for special topics only, Nhi mentioned that it is usually of interest for long-term trials as well.
    • Discussed HLT/HLGT. Confirmed past discussion on this - that our recommended static tables will still have SOC and PT only. HLT/HLGT more for exploratory - can look interactively (MedDRA at a glance now in Script Repository)
    • Discussed Clustering (e.g., acute MI, MI) - Need to continue this discussion
    • Group at CSS felt that relatedness should be a separate table - easier for coding.
    • AE tables - say "any adverse event" for top row
    • Brief discussion on a table with events alphabetical (without SOC)
    • AE figure - probably want a relative metric instead of difference, don't need p-value on the figure, improve title
    • Might want to expand to show displays with 3 treatments

  • Last revision by Jmbodart,10/13/2015