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Annual Meeting of the GTA
Current Regulatory and Scientific Issues in Genetic Toxicology

May 8-10, 2019
John M. Clayton Hall Conference Center
University of Delaware
Newark, DE

Special Event: GTA Workshop Preceding the Main Meeting
Wednesday, May 8, 2019

Statistical Approaches for Genetic Toxicology Assays

Background & Objectives:

The requirements for statistic in genetic toxicology guideline assays (or soon to be guideline assays) has become more stringent over the past 5 years. Regulations have changed around statistics for several assays already and it is expected that more will change as guidelines are updated and/or implemented. The issue that arises is that there is no clear guidance on the most appropriate statistics that should be conducted for each assay type. Due to this, laboratories across the genetic toxicology discipline are conducting these guideline assays in the same manner and obtaining the same data sets, yet are using different statistical methods for analysis.

The objective of this workshop is to work collectively with a panel of statisticians/subject matter experts to determine the most appropriate stats for genetic toxicology assays. The end goal is to publish a white paper/guidance document that can then been used across the genetic toxicology discipline, providing guidance on, and harmonizing, the statistical approaches used.

Prior to the workshop, willing laboratories submitted their data collection and statistical analysis methods for the in vitro Ames, chromosomal aberration, slide based micronucleus, flow based micronucleus, mouse lymphoma, and HPRT assays. This information was also submitted for the in vivo slide based micronucleus, flow based micronucleus, chromosomal aberration, comet, and Pig-A assays. A compilation of all submitted data was supplied to the panel for review prior to the meeting.

At this workshop, the panel of statisticians/subject matter experts will be providing feedback on what statistical approaches are most appropriate for each assay. Each assay will be discussed one-by-one in an open forum with the hopes that an agreement can be formed as to which statistical approach is best suited to the topic assay.

Meet the Panel

Carol Gleason, Bristol-Myers Squibb
Dr. John Green, John W Green Ecostatistical Consulting LLC
Dr. Dean (Dingzhou) Li, Pfizer
Dr. Andreas Zeller, Roche

Draft Agenda

3:30-3:35 pm                 Welcome and Overview of Workshop
                                       Stephanie Kellum

3:35-3:55 pm                 In Vitro Micronucleus (Slide and Flow Based)

3:55-4:15 pm                 In Vivo Micronucleus (Slide and Flow Based)

4:15-4:35 pm                 In Vivo Pig-A

4:35-4:45pm                 Coffee Break

4:45-5:05 pm                 In Vivo Comet

5:05-5:20 pm                 HPRT

5:20-5:40 pm                 Mouse Lymphoma

5:40-5:55 pm                 AMES

5:55-6:10 pm                 In Vivo Chromosomal Aberration

6:10-6:20 pm                 In Vitro Chromosomal Aberration  

6:20-6:30 pm                 Closing Remarks


Presentation in PDF

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HESI GTTC Workshop

Wednesday, May 8, 2019
Validation of New Approaches in Genetic Toxicology

     Univ of Delaware, Newark, DE
     Click here to  Register

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