Background Information on the FDA-Industry-Academia Working Group

Working Group Overview

Problem Statement

Most presentations on safety data convey information in tabular form. In general, tables are difficult to understand, especially when the data are complex. Graphics are more effective in conveying insight into complex safety data. The volume and complexity of current presentations of safety information complicate the review process and may cause important relationships to be missed over the life-cycle of the product. Rapid integration and dissemination of new information is often needed. The appropriate use of graphics can more effectively and efficiently communicate critical safety information to a variety of stakeholders. Encouragement of consistent or standardized presentation of visual information is needed. There is a need to promote best practices in the use of graphical visualization of clinical safety information.


This is a joint working group among FDA, Industry, and Academia.


The goal is to develop a palette of graphics for visualizations of clinical trial safety data.


Upon completion of this project the group will:
  1. Identify areas particularly applicable or useful to regulatory review in which graphics can enhance understanding of safety information.
  2. Develop a palette of statistical graphics for reporting on clinical trials safety data.
  3. Recommend graphics for clinical data based on good scientific principles and best practices.
  4. Create a publicly-available repository of sample graphics (ensuring appropriate credits are given for contributions), including data sets and code.
  5. Educate and engage stakeholders through outreach activities.
  6. Consider publishing with authorship/acknowledgments as is consistent with contributions and policy of the affiliated institution.

Project Scope

Project Includes

Project Excludes

Working Group Membership

Participation in the working group is based upon invitation and time/resources are based upon a volunteer basis. The following list contains the active membership within the working group along with a brief biographical sketch for each member.

FDA Participants

Industry Participants

Academia Participants

Additional Participants

Safety Meeting Minutes

The following are a collection of meeting minutes from meetings of the whole group.

Professional Meeting Information

The following pages are devoted to resources for professional meetings including a list of meetings, organizers, presenters, meeting materials, and slides.

Topic attachments
I Attachment Action Size Date Who Comment
Call_in_numbers.xlsxls Call_in_numbers.xls manage 29 K 20 Dec 2010 - 21:49 UnknownUser