SS P08 09July2015 Standard Scripts Project 08 Meeting

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Meeting Record

When: 08 July 2015
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Simin, Gustav, Wei, Terry, John A, Mercy, possibly others that I may have missed

  1. White Paper Updates


  • White Paper updates
    • Outliers/shifts - In progress.
    • AE - Discussed AE rate for patient years at risk. Options: separate shell, incorporate in existing shell, paragraph only. Per discussion, leaning toward separate shell. Position the shell as something to consider for AESIs. Include for individual studies only if long enough/enough patients. Add discussion on designs that include rescue. Discussed Common AEs figure. John noted there's a MPIP initiative (Pharma group). Risk differences help with 0 issue. The figure needs more footnotes (e.g., which treatment minus which). Add discussion on more complexity in models. Address CIs not agreeing with p-values. Discussed Eudra CT requirements (relatively new). Requires number of events under certain circumstances. Companies are trying to figure things out with this guidance (update standard output vs adding new tables). Terry will send background. We're leaning toward separate tables for number of events. Text can address recommendations on being in CSR vs not.
    • Hepatic - Terry working on it. Mary to provide internal criteria on who has an individual display. Probably don't need to worry about number of events or exposure-adjustment for this topic.

  • Last revision by MaryNilsson,02/4/2016