SS P08 Adverse Events White Paper

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White Paper Title and Lead

Title = Analyses and Displays Associated with Adverse Events – With a Focus on Phase 2-4 Clinical Trials and Integrated Summary Documents
Lead = Mary Nilsson, Nhi Beasley, Sheryl Treichel

Status

February 2017: White Paper finalized

25 August 2016: Draft 2 of the white paper is out for broad review. The plan is to finalize the white paper shortly after this review. Link to Draft White Paper. Comments are due 14 October 2016. We encourage anyone to participate in this review, including statisticians, medical, medical writing. There are 2 ways in which you can provide your comments:

  1. Enter your comments in the Discussion tab on this wiki page
  2. Provide comments to Sheryl Treichel, Nhi Beasley, and Mary Nilsson (smccoy@amgen.com, nhi.beasley@fda.hhs.gov, mnilsson@lilly.com).

2014:Draft 1 of the white paper is out for broad review. Link to Draft White Paper. Comments are due 01 December 2014. We encourage anyone to participate in this review, including statisticians, medical, medical writing. There are three ways in which you can provide your comments:

  1. Enter your comments in Agilewords (If you do not have an account with Agilewords, you need to apply for one - it is free). Link to Agilewords Version of the White Paper
  2. Enter your comments in the Discussion tab on this wiki page
  3. Provide comments to Sheryl Treichel (smccoy@amgen.com)

Reusable code for several tables and figures from the draft white paper is available in the Script Repository.

04 December 2014 Note: The review perod has been extended to 16 January 2015. Thank you to those who have already provided comments. Receiving comments before 01 December 2014 was helpful so that we can start working on the update! While we are working on the update, we are open to receiving additional comments before 16 January 2015.

Notes for next version

  • Consider making the volcano plot more prominent
  • Incorporate new references

History

Several topics were discussed during the PhUSE CSS March 2014 Meeting: See SS P08 18March2014 Standard Scripts Project 08 Meeting for meeting minutes.

Agenda for CSS 2016 for this white paper

  • Relatedness assessment by the investigator: There seems to be little regulatory interest yet it's common for industry to create summary tables using relatedness. Should we discontinue the practice of routinely creating summary tables incorporating relatedness and only create such tables if deemed helpful for a particular event of interest and/or if required per a specific regulatory interaction?
  • Listings: A lot of listings are quite common in practice. Should we provide recommendations on what listings are value-added (if any)? Does anyone have experience with not providing as many listings and was that OK?
  • Clustering/Consolidating MedDRA PTs that might be considered synonymous: There is a discussion in the FDA Safety Reviewer Guidance about potentially grouping terms that are very similar. While common for adverse events of special interest, it may not be as common for signal detection. The goal is to not miss a signal by having PTs too fine, and for adverse reactions, the goal is to have an appropriate incidence in a label. We can discuss recommendations on how to handle this. Focus on AESIs only? Recommend such a practice for all observed PTs at time of submission vs each CSR? Network with MedDRA to discuss creating a standard MedDRA level for this purpose?
  • All AE tables: Discuss format/footnotes etc. (e.g., SMQ table and KM plot might need special attention)
  • Discuss scope: Unlike the white papers for labs/vitals/ECGs, we're drafting the white paper to include a couple common displays that might be useful for event-based AESIs (counting events instead of patients and time-to-event). Any issues with that? Any other ideas?
  • Discuss events occurring between informed consent and start of treatment. Confirm that we think it's OK that those are not part of any summary table (only in listings and/or data).

Notes

Category Identification


Last revised by MaryNilsson,05/31/2017