WG5 Project 07

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Revision as of 07:41, 11 July 2019 by WendyDobson (talk | contribs) (Project Progress)
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Project Team

Project Lead:

Jared Slain and Wendy Dobson

Project Members:

We need your help! Please contact workinggroups@phuse.eu if you would like to volunteer for this project.

Project Description

Project Name
Communication, Promotion and Education
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

2019 Accomplishments

Webinar 24.04.19 Safety Analytics CSS Workshop Mary Nilsson & Nhi Beasley
Webinar 23.01.19 Presentation on the Script for Metadata for Sharing Final White Paper Hanming Tu & Bob Friedman
DIA 2019 Abstract submitted for the Annual DIA Conference Link to abstract
Squarespace Our new initiative on Education. Click here to find out more about our Script Repository Jared Slain

Project Progress

2018 Milestones
Topic Presentation Presenter
PhUSETube Publication Script Metadata for Sharing Hanming Tu
PhUSETube Publication Study-Size Adjusted Percentages. Why, What, When Topics on Pooling Data from Multiple Studies Brenda Crowe
White Paper Publication Version 2.0 Analyses & Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinical Trials and Integrated Summary Documents Mary Nilsson
Standard Analyses & Code Sharing Presentation to FDA Working Group Overview Mary Nilsson & Hanming Tu
Introduction to Poster for Frankfurt EU Connect - Streamline the Collaboration From White Paper Targets (TFLs) to Shareable Scripts Hanming Tu
Webinar GitHub Environment Hanming Tu
Webinar CSS 2018 Working Group Output Mary Nilsson & Hanming Tu
CSS 2018 Presentations Project Leads Slide Decks All Project Leads
Working Group All Hands Meeting 29th Nov Mary Nilsson & Hanming Tu
ADW & Data Visualisation Meeting Submissions Sub Team Project Mary Nilsson

2018 Posters/Abstracts

Topic Presentation Presenter
Frankfurt EU Connect Working Group Overview Mary Nilsson & Hanming Tu
MWSUG Working Group Overview Nancy Brucken and Jared Slain
Abstract on Standard Analyses & Displays for Common Clinical Trial Data - An Industry-wide Initiative JSM 30Jul2018 Hanming Tu
Spotfire User Group Meeting Japan Spotfire User Group Rebeka Revis
WHODrug User Group Meeting Recommended Summaries of Medication Data Hanming Tu & Mary Nilsson

Upcoming Opportunities


Date Event Key Dates Location
Jun 9-11 PhUSE Computational Science Symposium Registration Open Silver Spring, Maryland, USA
Jun 12 Advancing the Development and Implementation of Analysis Data Standards: Key challenges and opportunities Registration Open Silver Spring, Maryland, USA
Jun 16-19 US PharmaSUG Registration Open Philadelphia, Pennsylvania
Jun 6 PhUSE Single Day Event Registration Open Copenhagen, Denmark
Jul 18 PhUSE Single Day Event Registration Opens June Hoboken, New Jersey
Jul 27 PhUSE Single Day Event Registration opens June Bengaluru, India
Jun 23-27 USA DIA Global Registration Open. Call for Papers closes 14th Feb San Diego
Jun 28 WHODrug User Group in connection with MedDRA TBC San Diego, USA
Jul 10-12 CDISC Japanese Interchange Registration Open Tokyo, Japan
Jul 27 - Aug 1 ASA & JSM Registration Opens May 1 Denver, Colorado
Aug 15 PhUSE Single Day Event Registration opens July Mississauga, ON Canada
Aug 30-31 Chinese PharmaSUG TBC Shanghai, China
Sep 11-13 W Edwards Deming - Management Method for Owners & Executives Registration Open Tipp City, OH, USA
Sep TBC PhUSE Single Day Event Registration opens August Beerse, Belguim
Sep 26 PhUSE Single Day Event Registration opens August North Wales, Pennsylvania
Sep TBC CDISC Chinese Interchange TBC Beijing, China
Oct 16-17 CDISC USA Interchange Posters / Abstracts Open San Diego, California
Oct TBC PhUSE Single Day Event Registration opens September Cincinnati, Ohio
Oct TBC PhUSE Single Day Event Registration opens September Chennai, India
Nov 10-13 PhUSE EU Connect Early Bird Closes 27th July Amsterdam, The Netherlands
Nov TBC PhUSE Single Day Event Registration opens October Bloemfontein, South Africa
Nov TBC PhUSE Single Day Event Registration opens October Shanghai, China
Dec 5 PhUSE Single Day Event Registration opens November Durham, North Carolina

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
14Dec2018 Repository Front End Requirements Minutes
30Nov2018 Organization of Past Presentation Materials Minutes
16Nov2018 Repository and Safety Analytics Front Ends Minutes
02Nov2018 Teamworks Demo Minutes
19Oct2018 Review Priorities Minutes
04Oct2018 Early October Meeting Minutes
07Sep2018 Focus on Repository Front Door Minutes
24Aug2018 WG Presentation to FDA Minutes
13July2018 Friday the 13th of July Meeting 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 WendyDobson,07/11/2019