Difference between revisions of "WG5 Project 07"

Latest revision as of 09:38, 5 September 2019

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

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

2019 Accomplishments

Project Progress

2018 Milestones

2018 Posters/Abstracts

Upcoming Opportunities

2019

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

Last revised by WendyDobson,09/5/2019