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.
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:
- Identify areas particularly applicable or useful to regulatory review in which graphics can enhance understanding of safety information.
- Develop a palette of statistical graphics for reporting on clinical trials safety data.
- Recommend graphics for clinical data based on good scientific principles and best practices.
- Create a publicly-available repository of sample graphics (ensuring appropriate credits are given for contributions), including data sets and code.
- Educate and engage stakeholders through outreach activities.
- 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
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
- George Rochester (Co-Chair) - CDER:
- Mat Soukup ( Co-Chair) - CDER: Mat Soukup, Ph.D. is currently acting Team Lead for the Safety Division within the Office of Biostatistics at the CDER. He has been involved in drug and biologics review for more than 5 years. In addition to his extensive IND and NDA/BLA reviews, he has been at the forefront on the use of statistical graphics for conveying safety and efficacy data collected in clinical trial research. He has also been active in developing ways to collaborate with industry and academia to improve the business of scientific research across organizations.
- Tara Bell (Project Support) - CDER:
- Robert Fiorentino - CDER:
- Richard Forshee - CBER: Rich Forshee is the Associate Director for Research in the Office of Biostatistics and Epidemiology at CBER. He is involved in a wide range of interdisciplinary research projects related to biologics products. High-quality statistical graphs are one of the most important tools for communicating the results of the this research to the wide range of interested stakeholders. He joined the FDA in 2008, and he has more than 12 years of experience in academia at Georgetown University, Virginia Tech (National Capital Region), and most recently the University of Maryland. Rich has been interested in statistical graphics since his graduate school days at the University of Michigan.
- Eric Frimpong - CDER:
- Antonio Paredes - CDER:
- Jeff Summers - CDER:
Industry Participants
- Ken Koury (Co-Chair) - Schering Plough:
- Brenda Crowe (Co-Chair) - Eli Lilly and Company: Brenda Crowe is a Research Advisor at Eli Lilly and Company. She provides statistical expertise to Lilly's Global Patient Safety division.
- Richard Anziano (Lead: ECG/Vitals) - Pfizer: Rich has nearly 20 years of experience in the pharmaceutical industry. He has worked in phases 1-3 in many different disease areas and currently leads a group of statisticians working in Alzheimer's, Pain, and other Neuroscience indications. Rich has a keen interest in the use of graphics for effective and efficient interpretation of data from clinical trials.
- Susan Duke (Lead: General Principles) - GSK: Co-lead an internal graphics team from 2004-2011, which delivered the Amit, et al paper on safety graphics and an internal graphics catalogue website. Susan is interested in graphic design, also in furthering collaboration amongst statisticians to increase the value and speed of our collaborative efforts via electronic means. Currently Susan is a manager in GSK's benefit risk evaluation team.
- Robert Gordon (Lead: Labs/Liver) - Johnson and Johnson: Robert "Mac" Gordon is currently a Biostatistician at J&J working both as a Clinical Trial Team Statistical Lead and a Clinical Safety Statistician with a focus on data visualization, signal detection and the incorporation of graphics and interactive tools into clinical data analysis. He has lead numerous efforts to incorporate graphical tools and efficiencies into the Pharmacovigilance process as well as offering graphical insight into the clinical trial process. He has over 9 years of experience in Pharmacovigilance and clinical trial statistics focusing on graphics, signal detection and data visualization and analysis.
- Andreas Kraus -_Actelion_
- Fabrice Bancken - Novartis: Fabrice provides statistical expertise to the Drug Safety & Epidemiology group in Novartis, on diverse quantitative safety topics. At previous company, led an internal graphics team and is still a key point of contact now at Novartis for best graphing principles and graphics design.
- Andreas Bruckner - Bayer Healthcare:Andreas Brueckner has many years of experience in analyzing integrated clinical databases. He has worked in pharmacovigilance and was involved in epidemiological studies, signal detection and the analysis of data from spontaneous report databases. Graphical Analysis are one of his passions, with a strong focus on visualizing data from large patient populations.
- Larry Gould - Merck:
- Liping Huang (Lead: Adverse Events) - Roche:
- Qi Jiang - Amgen: Qi Jiang, Ph.D., has many years experience in early and late stage clinical development across a spectrum of therapeutic areas. Has worked both in the pharmaceutical industry and in an academic setting, and so has seen a number of organizations' processes. Very interested in safety graphics presentation. Safety graphics is an efficient way to visualize complex information - well designed graphs help to understand the safety data.
Academia Participants
- Frank Harrell - Vanderbilt University:
- Mary Banach - UC Davis:Mary Banach, Ph.D., M.P.H. has worked as Program Manager on CTSpedia since its inception at UCSF. Her focus is on how you collaborate and build professional education communities. She has managed diagnostic and treatment clinical trials for the pharmaceutical industry and the Division of AIDS and appreciates how difficult it is to communicate clinical trial findings to both the scientific and lay communities.
Additional Participants
- Catherine Njue - Health Canada:
The following are a collection of meeting minutes from meetings of the whole group.
The following pages are devoted to resources for professional meetings including a list of meetings, organizers, presenters, meeting materials, and slides.
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