FDA/Industry/Academia Safety Graphic Working Group Charter

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.

Description

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

Goal

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

Objectives

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

• Graphics to convey pre-approval clinical safety information, typically submitted in support of an integrated summary of safety (ISS)
• Static graphics represented in; color, black and white; and grayscale
• Graphs for both descriptive and inferential purposes
• Static graphics should be printable
• Develop tools that will aid in the production of new drugs

Project Excludes

• Spontaneous reporting or epidemiological case control studies
• Dynamic graphics

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Topic revision: 09 Feb 2011, MatSoukup

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