SS P08 Central Tendency White Paper

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White Paper Title and Lead

Title = Analyses and Displays Associated with Measures of Central Tendency – Focus on Vital Sign, Electrocardiogram, and Laboratory Analyte Measurements in Phase 2-4 Clinical Trials and Integrated Submission Documents
Lead = Mary Nilsson (MNilsson@Lilly.com)

Status

The white paper was finalized October 2013! The official location of the final white paper can be found on The PhUSE Home Page, then click Publications

Reusable code for several of the tables and figures are in the Script Repository.

Plan

There are plans to maintain this white paper. Creating version 2 will likely begin in early 2015. Feel free to put suggestions in the Discussion tab on this wiki page.

History

First draft sent for review 12 June 2012
Second draft sent for review 29 October 2012: Click here to see 2nd Draft
Third draft sent for review 19 February 2013: Click here to see 3rd Draft
During the March 2013 PhUSE CSS conference, we discussed several issues (for minutes, see 19Mar2013 White Paper Breakout Session).
Fourth draft sent for review 20 September 2013: Click here to see 4th Draft
The white paper was finalized on 10 October 2013: Click here to see the Final White Paper.
The white paper was used as requirements for the Script-a-thon in March 2014.

Version 2 Considerations

  • Change Submission to Summary in the title per feedback on other white papers
  • Put the TFLs that were considered but not recommended in its own section at the end
  • Add ADaM results meta-data
  • Add additional sentence on collection per feedback on other white papers (review all common text for latest edits)
  • More on central versus local - need assay consistency to combine (Percent ULN/LLN may not be appropriate unless limit development method was consistent)
  • More on labs that appear numeric but should be analyzed qualitatively (atypical lymphocyes example - some text in outlier/shift end of May/early June draft?)
  • Consider LSMeans instead of means for Baseline to Endpoint
  • Mention that hepatic has its own white paper
  • In the example SAP text, reference the PhUSE white papers
  • Improve Section 8.2. OK if the randomization ratio is consistent across studies. Otherwise, really not recommended even if have the correct meta-analysis method.
  • Add the Clinical Review Template as a key resource (instead of FDA safety reviewer guidance?)
  • Possibly address what is best to do interactively versus in a static manner and remember to include in example SAP language.
  • Add CIOMS VI as a resource
  • For figures 7.6 and 7.8, add clarity that only includes patients with both a baseline and postbaseline (even for the baseline summaries)
  • Figure 7.8, add LSMeans, take out TE high/low?

Notes

  • We might want to create educational materials related to content (maybe short video clips). Example - teaching how to read a boxplot.


Category Identification


Last revised by MaryNilsson,08/26/2016