Overview

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Welcome to the Evidence-based Toxicology (EBT) course. In medicine and healthcare, evidence-based medicine has revolutionized the way that information is evaluated transparently and objectively. Over the past ten years, a movement in North America and Europe has attempted to translate this revolution to the field of toxicology. The Center for Alternatives to Animal Testing (CAAT) within the department of Environmental Health and Engineering at the Johns Hopkins Bloomberg School of Public Health hosts the first chair for EBT and the secretariat for the EBT Collaboration on both sides of the Atlantic. Based on the Cochrane Collaboration in Evidence-based Medicine, the EBT Collaboration was established at the CAAT to foster the development of a process for quality assurance of new toxicity tests for the assessment of safety in humans and the environment. Regulatory safety sciences have undergone remarkably little change in the past fifty years. At the same time, our knowledge in the life sciences is doubling about every seven years. Systematic review and related evidence-based approaches are beginning to be adapted by regulatory agencies like the Environment Protection Agency (EPA), the European Food Safety Authority (EFSA), and the US National Toxicology Program. They provide transparent, objective, and consistent tools to identify, select, appraise, and extract evidence across studies. This course will showcase these emerging efforts and address opportunities and challenges to the expanded use of these tools within toxicology.

Syllabus

Introduction & Shortcomings of Current Approaches

This module introduces you to the course, outlines the shortcomings of current toxicity testing approaches, and shows how EBT can help to overcome these shortcomings.

History and Causation

This module explains how evidence-based toxicology originated and describes the driving forces for the initiative. In the second lesson, you will learn how to distinguish between correlation and causation as well as the main problems with drawing conclusions on the basis of correlations. The Bradford Hill criteria are introduced, along with examples for each criterion. You will also learn about mechanistic toxicology and mechanistic validation.

Systematic Review and Meta-Analysis

This module shows how to perform systematic reviews and meta-analyses. You will learn the history of both methods and will receive step-by-step instructions on how to perform systematic reviews and meta-analyses using examples from the research activities of the instructors.

Risk of Bias & Application to Test Methods Comparison

This module teaches you about possible biases that can be introduced at different stages of research. Each bias is explained with examples, including solutions for overcoming those biases. The second lesson covers systematic review of the zebrafish embryotoxicity test as a case study conducted by the Evidence-based Toxicology Collaboration (EBTC). You will go through all of the steps of the systematic review again to imprint the knowledge from module 3, but this systematic review will be related to a toxicological method.

Quality Assurance, Good Practices, and Validation

Quality control is a very important aspect of not only modern toxicology but the entirety of life sciences. The first lesson in this module demonstrates the importance of performing quality control on your experiments. The second lesson is connected with the first one because validation of an alternative method requires highly standardized protocols and quality control at each step. This lesson teaches you different aspects of alternatives methods validation, how to perform classical validation, its pitfalls, and strategies to overcome them.

Biometrical Tools & Future Perspectives

Evidence-based toxicology requires some knowledge of bioinformatics. The first lesson in the module teaches you some biostatistical tools you can apply when analyzing predectivity, specificity, and sensitivity of a method. You will also learn how to identify biases in a study with the help of bioinformatics. Evidence-based principles can be applied to every question you might have, even to which pizza to order tonight. You will learn the difference between eminence-based vs. evidence-based approaches. You will learn what is driving the lack of reproducibility and how evidence-based approaches should help to overcome the reproducibility crisis in science, which is explained with examples of experimental design, wrong models, poor quality of the cell cultures, etc.

Summative Assessment - Systematic Review Assignment

The final week of the course is devoted to completing the Systematic Review Assignment. You will use SysRev to review at least 20 abstracts, apply inclusion and exclusion criteria, render decisions, and resolve conflicts with other reviewers.