EBTC Newsletter #15, December 2016
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EBTC Newsletter


Welcome to the EBTC Newsletter! In this new issue we introduce the newest member of the EBTC Board of Trustees Dr. Emily Sena. Emily is a Research Fellow at the Centre for Clinical Brain Sciences, University of Edinburgh and the Convener of CAMARADES. We are excited to welcome Emily to the EBTC and have asked her to briefly introduce herself, tell us about CAMARADES, and describe why she joined the EBTC and what she expects from the group:
“I am a research fellow who primarily dissects and seeks to understand the world of animal efficacy studies. I came into this work as an undergraduate student mentored by a neurologist and a neuroscience basic scientist. They wanted to identify an intervention to treat stroke, that had sufficient evidence of efficacy in animal studies, to take forward to test in humans. The decision to apply a systematic approach to address this problem was two-fold. Firstly, at least for stroke research, so many interventions appeared to be effective in animals but when these same interventions were taken forward to be tested in humans in a clinical trial setting they failed to show the same effects. In 2006, O’Collins and colleagues (including my two mentors) reported that 374 interventions have been reported to be effective in experimental stroke; 97 were tested in clinical trials but only one of these was shown to be effective. Clearly, choosing a “winner” was neither simple or easy. Secondly, systematic scrutiny of a body of literature to inform decision making was now routine in clinical medicine and considered highly robust due to its transparent and objective nature. It was from here that the CAMARADES collaboration was born.

Ten years later I am now convenor of CAMARADES; it is a multicentre international collaboration that facilitates the pooling and analysis of data from a range of disease models across the basic sciences. Our direction quickly changed from just trying to pick a winner. It became abundantly clear from our systematic reviews that much of the literature was not sufficiently robust to instil confidence in the results presented. Instead, we have been able to provide empirical evidence of many shortcomings in experimental design and reporting that result in overestimations or exaggerations in treatment effects. Our purpose is to provide an evidence-base to understand the critical facets of translational medicine, to improve the validity and quality of preclinical research and to develop novel hypotheses to test in the laboratory. Our hope is this will increase the likelihood of translation from bench to bedside.  

Joining the board of trustees at EBTC is a great honour and exciting opportunity. Evidently, they are many similarities (and obvious differences) between CAMARADES and EBTC, and mutually beneficial lessons to be learned. Applying meta-research techniques to new research domains to develop an evidence base is not straightforward. There are practical challenges in performing the research itself that are domain specific, but also challenges in communicating these data and findings that is useful to a field not familiar with it. EBTC’s mission is to provide transparent, objective and scientifically valid evaluations of evidence to inform decisions. I hope my experience at the centre of an emerging discipline and my observations of how CAMARADES has evolved over the last eleven years will be an asset to EBTC. My membership on the board of trustees is a task I endeavour to undertake to the best of my abilities and with enthusiasm and dedication." Emily Sena

Community News

Implementing systematic review methods in chemical risk assessment 

The Lancaster Environment Centre in association with the Royal Society of Chemistry Toxicology Group organized a workshop on implementing systematic review methods in chemical risk assessment. The meeting was held in London on December 1-2, 2016, and included approximately 35 invited experts from Europe and the United States. The workshop was co-chaired by Paul Whaley, who is member of the EBTC Scientific Advisory Council (SAC), and featured the participation of other EBTC staff, SAC and Board members: Sebastian Hoffmann, Rob de Vries, Andrew Rooney, Daniele Wikoff. The agenda focused on the challenges of problem formulation and quality assurance. The issue of problem formulation was recognized as the crucial step in planning of a chemical risk assessment. While guided by underlying principles, such as transparency and stakeholder involvement, the risk assessment frame was understood to be primarly determined by context, purpose and prioritization. This framework would lead to the formulation of a problem that would be fine-tuned in an iterative fashion during the protocol development. Criteria for the conduct of systematic reviews for chemical risk assessment were discussed in break-out groups. Sebastian Hoffmann presented the learnings from an ongoing systematic review of the performance of the zebrafish embryo test to detect chemical-induced malformations.

Society for Risk Analysis Annual Meeting December 11-15, 2016, San Diego, CA

 We invite those of you who are attending next week’s annual meeting of the Society for Risk Analysis to view the EBTC poster (#185) on “The role of systematic review in risk assessment – the missing link between the objectivity and transparency of scientific evidence and confidence of regulatory decisions.” The poster reception will be held Monday evening with presenters available for questions and discussion.  Attendees will be encourage to vote for the best poster awards; please come and talk to us at the poster and consider the EBTC poster in your voting. We hope to see you in San Diego!

EBTC Publications and Projects Update

NEW! Publication from the EBTC staff: a book chapter in the new Springer book “Validation of Alternative Methods for Toxicity Testing. The chapter information: Evidence-Based Toxicology. Hoffmann S, Hartung T, Stephens M. Adv Exp Med Biol. 2016;856:231-241.
Tox 21 / ToxCast data analysis work group: This work group, led by Dr. Hubert Dirven at the The Norwegian Health Institute, is focused on applying evidence-based methods to the analysis of in vitro data from programs such as Tox21 and US EPA ToxCastTM. The group has developed a protocol for a pilot systematic scoping review of the animal studies on 10 chemicals that will serve as a comparator to the ToxCastTM data set on the same chemicals. The literature search has been conducted and subsequent steps are about to begin.
Empirical risk of bias work group: This working group, led by Dr. Kristina Thayer, Director of Office of Health Assessment and Translation (OHAT) at the National Institutes of Environmental Health Sciences (NIEHS), is developing an empirical risk of bias tool for in vitro studies, compatible with the integration of these data into risk assessments to inform regulatory decisions.
Zebrafish Embryotoxicity work group: The Zebrafish Embryotoxicity Work Group is carrying out a systematic review of the Zebrafish Embryo Test as a predictor of in the outcome from standard mammalian (rat and rabbit) test for developmental toxicity, the Organization for Economic Cooperation and Development’s test guideline 414, “Prenatal Developmental Toxicity Study.” A pilot version of the review has been completed. In the pilot, 1,442 mammalian studies were analyzed, with 20 of these meeting the inclusion/exclusion criteria. A risk of bias tool for animal studies (developed and validated at the  SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) was applied to these studies. The work group is writing up the results of the pilot study as well as a separate paper on lessons learned. In these publications we will describe the issues encountered during all stages of this systematic review and the results of the risk of bias analysis. For the definitive review, the literature search has been updated and has returned 7,694 zebrafish studies. We have seven active reviewers screening the titles and abstracts of these papers and we are looking for more reviewers to get the screening completed. Please contact us to get training in evidence-based methods and to join the group!
Please let us know (contact us) if you would like to get involved in any of these work groups or have some thoughts or suggestions. 
About EBTC

The EBTC is an open international collaboration of leading academic, government, non-profit and industry organizations, formed in order to foster collaborative development and adoption of evidence-based methodologies in toxicology. It is governed by the Board of Trustees.

The EBTC Board of Trustees
Dr. John “Jack” R. Fowle III - President of the Board
Dr. Rob de Vries - Vice President of the Board and Chair ad interim of the Scientific Advisory Council
Dr. Nancy Beck
Dr. James J. Freeman
Dr. Thomas Hartung
Dr. Sebastian Hoffmann
Dr. Ian Kimber
Dr. Andrew Rooney
Dr. Emily Sena
Dr. Martin L. Stephens
Dr. Katya Tsaioun
Dr. Didier Verloo

To learn more about the EBTC governance structure, funding and to learn more about the EBTC Board members click here.
The EBTC has a new website! The new site reflects the EBTC’s status as one of the centers and affiliated programs of Johns Hopkins Bloomberg School of Public Health. Please note the new URL, although if you have bookmarked the old one it will automatically forward to the new:
Copyright © 2016 EBTC, All rights reserved.

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Johns Hopkins Bloomberg School of Public Health
Evidence-based Toxicology Collaboration
615 N. Wolfe Street, W7032
Baltimore, MD 21205

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