EBTC involvement at SOT 2019

This year at SOT there will be 47 talks and posters on systematic review methods, compared to 4 in 2015. EBTC staff, Board and Scientific Advisory Council (SAC) members are contributing to almost half of these. (EBTC SAC Vice-Chair Daniele Wikoff is chairing, presenting at and contributing to 9 sessions and posters this year.)

Sunday March 10: A Continuing Education session chaired by EBTC's Scientific Advisory Council vice-chair Daniele Wikoff. The session, "Conducting Systematic Review in Toxicology - Why, When, How?" introduces the SR concept and features talks by EBTC Board member Emily Sena, on assessment of study quality, and EBTC Research Fellow Paul Whaley on reporting and critically appraising SRs.

Wednesday March 13: EBTC's Katya Tsaioun will deliver a platform presentation on EBTC's work on off-target activity of troglitazone and rosiglitazone, analysed using evidence-based approaches in three evidence streams. This talk is part of the platform session “Safety assessment of pharmaceuticals in drug development”.

On Wednesday afternoon Katya will then discuss the role of systematic literature review in retrospective analysis of existing data on the example of zebrafish embryotoxicity study in the session on the utility of in vitro developmental toxicity assays and building IATAs.

CAAT visiting scholar Sevcan Akgün Olmez is presenting a poster on Wednesday morning on the results of the pilot study of EBTC’s systematic review of the zebrafish embryotoxicity test (poster board 3182).

US NAS Workshops Update

EBTC's Katya Tsaioun was on the organizing committee for the National Academies of Sciences workshop on December 10 and 11, 2018 in Washington, DC: "Strategies and Tools for Conducting Systematic Reviews of Mechanistic Data to Support Chemical Assessments". See the full agenda, watch the presentations, and download the posters presented at the workshop.

The second workshop that was scheduled for March 28-29, 2019 on integration of evidence streams in risk assessment, which builds upon the outcomes of the 2017 EBTC/EFSA Colloquium on evidence integration, has been postponed due to the partial US government shutdown.

New Publications

EBTC staff are co-authors on two new publications.

• How to use the new ROBINS risk of bias assessment tool in the context of GRADE assessments of certainty in the evidence. (Open access, view here.)
• A summary of a series of initiatives geared towards improving the quality of in vitro work and its reporting, leading to Good In Vitro Reporting Standards (GIVReSt). (Open access, view here.)

Tox21 Working Group Protocols 

EBTC is pleased to announce the publication of the protocols for the EBTC Tox21 Working Group and welcomes feedback from all stakeholders. The analysis of the first pair of the drugs in glitazone series has been completed and a manuscript is in preparation.

The three protocols are for:

• Systematic review of animal and human randomized clinical trials
• Analysis of the US EPA ToxCast data
• Analysis of the WHO Vigibase pharmacovigilance (“Real World Evidence”) data

EFSA / BfR conference on uncertainty

EFSA, the European Food Safety Authority, and the BfR, the German Federal Institute for Risk Assessment, are co-organising an International Conference on Uncertainty in Risk Analysis in Berlin (Germany) on 20-22 February 2019.

This conference will provide a forum for scientists to discuss uncertainty analysis in the context of food safety and human health, covering methods in uncertainty analysis, communication of uncertainties, and uncertainty in decision making.

The EBTC will be represented by Sebastian Hoffmann, who will talk about ‘How evidence-based methodology can contribute to uncertainty assessment’.

GRADE Working Group pre-meeting

On 13 and 14 June 2019, the next general meeting of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group will take place in Hamilton, Canada.

This meeting is being sponsored by EBTC and a substantial part of the agenda will be dedicated to assessing certainty in mechanistic evidence (for example, how to characterise the indirectness of this type of evidence in terms of both population and outcomes).

On 12 June, EBTC will organize a pre-meeting in which other aspects of mechanistic evidence will be discussed, including the role this type of evidence should play in risk assessments and the consequences for evaluating this evidence in systematic reviews.