WG5 Project 07

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Project Team

Project Lead
Jared Slain and Wendy Dobson
Project Members

We need your help! Please contact a member of the working group if you would like to volunteer for this project.

Project Description

Project Name
Communication, Promotion and Education
Description
The success of working group “Standard Analyses and Code Sharing” relies on the acceptance, input, feedback and further development from/by the user community. A main priority will be to develop a Communication Plan that conceptualizes efficient ways to communicate working group progress and results, e.g. white papers, and the call for scripts. It will define target groups, timing, communication channels, and the presentation.

Project Progress

Milestones

2018 Posters/Abstracts


JSM 30Jul2018 - Abstract on Standard Analyses & Displays for Common Clinical Trial Data - An Industry-wide Initiative

Presentation - Japan Spotfire User Group - Rebeka Revis

Recommended Summaries of Medication Data. WHODrug User Group Meeting - Hanming Tu & Mary Nilsson

Upcoming Opportunities

2018

Date Event Submission Deadline Location
Throughout 2018 PhUSE Single Day Events Varies Global
PhUSE CSS 2018 Closed Posters and feedback to be added
8Apr2018-11Apr2018 SAS Global Forum 2018 Closed Denver, CO (USA)
17Apr-19Apr2018 DIA Europe Closed Basel, Switzerland
23Apr2018-27Apr2018 CDISC European InterChange Closed Berlin
29Apr2018-2May2018 PharmaSUG 2018 Closed Seattle, WA (USA)
16May2018-19May2018 ASA Symposium on Data Science & Statistics Closed Reston, Virginia
20May2018-23May2018 Society for Clinical Trials (SCT) Closed Portland, Oregon
3Jun2018-6Jun2018 PhUSE US Annual Conference Sold Out Raleigh, NC (USA)
24Jun2018-28Jun2018 DIA 2018 Closed Boston, MA (USA)
29Jun2018 WHODrug User Group Meeting Closed Boston, MA (USA)
09Jul2018-11Jul2018 CDISC Japan Interchange Closed Tokyo
28Jul2018 - 02Aug2018 ASA Joint Statistical Meetings (JSM) Unknown Vancouver, Canada
06-07Sept 2018 CDISC China Interchange Unknown Beijing
05Sept2018 - 07Sept2018 Western Users of SAS Software 30Jul Sacramento, USA
12Sept-14Sept2018 ASA Industry Statistics Workshop Closed Washington
27Sep2018 WHODrug User Group Meeting Unknown San Francisco, CA (USA)
30Sept2018-02Oct2018 2018 MidWest SAS® Users Group Conference Closed Indianapolis, IN (USA)
08Oct2018-12Oct2018 CDISC US Interchange Unknown Bethesda, MD
4Nov-7Nov2018 PhUSE Annual European Conference Early Bird 27Jul Frankfurt, Germany
05-06OCTl2018 The W Edwards Deming Institute Early Bird 1AUG Manhattan Beach, CA

Archived Events & Publications

Previous conferences and presentations

Action Items

  • Implement Team (we need Writers, Networkers, Twitters)
  • "Something big" for 2017-2018 (and beyond)!
  • Increase visibility of White Papers and code repository on the PhUSE website
  • Create a video on PhUSE Tube how to work with the repository
  • Gain greater access to other interest groups
  • Inspire discussions & participation
  • Present progress at conferences
  • Formal publication of White Papers

Journal Article Outline

  • Journal pertaining to analyses and displays
    • Key Messages or issues we're trying to address with the paper
      • There are basic safety analytical principles that are not well understood - those involved with safety should obtain a base knowledge
      • Certain behaviors within current practice need to stop (analyses with confounding, analyses with bias, lack of stratification, etc). We might need to provide examples of issues in current practice (eg, from briefing documents and/or labels). We might want a separate manuscript just on pooling issues with the example, the problem, and what could have been done instead.
      • Current practice can be improved (especially with integrated analyses, but individual study analyses as well)
      • While there are existing recommendations for analyses/displays, the rationale behind them and how to read them, and where they fit in the overall interpretation is not well understood
      • Safety is not that easy, and does require careful planning
      • Need to raise the bar - Avoid confounding, avoid bias, include stratification by study where warranted, include indirect methodology where warranted, how to read certain displays and what to look for (box plot, spaghetti plot, etc), mean changes over time aren't the best for persistent/transient questions, leverage interactive capabilities
      • To raise the bar, team members should take basic training specific to safety analyses prior to team participation (DIA training, PhUSE white papers, PhUSEtube videos, etc.). We can provide a suggested list of reading/training in the manuscript with a link to a wiki page that allows for updating and discussion.
      • Common challenges/pitfalls and general ways to address the challenges
    • Signal detection, signal clarification, signal communication
      • Get clarity on different needs
    • Be a little provacative
      • Point out mistakes that are being made
      • Big signals aren't being missed, but we could be doing better: exposure times calculated incorrectly, data pooling
      • Wasted energy creating and reviewing data that aren't helpful
      • Allowing some interactive capabilities
    • Draft Titles
      • Raising the Bar in Premarketing Clinical Trial Safety Assessment
      • Clinical Trial Safety Analyses - Why isn't it easy?
    • Notes - Can we get access to the DIA Training "Premarketing Clinical Trial Safety" so we don't duplicate information?

Group Meetings

Date Topic Minutes
29June2018 June Meeting Minutes
18May2018 General Discussion and More PhUSE Web Design Work Minutes
04May2018 Continuing Discussions Minutes
20April2018 Upcoming Webinar and PhUSE Web Design Minutes
06April2018 PhUSE Tube Video Creation and Misc Topics Minutes
28March2018 2018 CSS Discussion Continuation Minutes
4-6March2018 Notes captured during CSS Breakout Sessions
28Feb2018 Preparation for CSS 2018 Minutes
24Jan2018 Early 2018, Something Big Deliverables Minutes
22Nov2017 November Meeting (Potpourri of items) Minutes
26June2017 Something Big - June Meeting Minutes
10May2017 Kickoff for Something Big Minutes


Last revised by Jared s,07/13/2018