Evidence-based toxicology

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The discipline of evidence-based toxicology (EBT) strives to transparently, consistently, and objectively assess available scientific evidence in order to answer questions in toxicology, [1] the study of the adverse effects of chemical, physical, or biological agents on living organisms and the environment, including the prevention and amelioration of such effects. [2] EBT has the potential to address concerns in the toxicological community about the limitations of current approaches to assessing the state of the science. [3] [4] These include concerns related to transparency in decision making, synthesis of different types of evidence, and the assessment of bias and credibility. [5] [6] [7] Evidence-based toxicology has its roots in the larger movement towards evidence-based practices.

Contents

By analogy to evidence-based medicine (EBM), [8] the umbrella term evidence-based toxicology (EBT) has been coined to group all approaches intended to better implement the above-mentioned evidence-based principles in toxicology in general and in toxicological decision-making in particular. Besides systematic reviews, the core evidence-based tool, such approaches include inter alia the establishment and universal use of a common ontology, justified design and rigorous conduct of studies, consistently structured and detailed reporting of experimental evidence, probabilistic uncertainty and risk assessment, and the development of synthesis methodology to integrate evidence from diverse evidence streams, e.g. from human observational studies, animal studies, in vitro studies and in silico modeling. A main initial impetus for translating evidence-based approaches to toxicology was the need to improve the performance assessment of toxicological test methods. [9] The U.S. National Research Council (NRC) concurs that new means of assessment are needed to keep pace with recent advances in the development of toxicological test methods, capitalizing on enhanced scientific understanding through modern biochemistry and molecular biology. [10]

A key tool in evidence-based medicine that holds promise for EBT is the systematic review. Historically, authors of reviews assessing the results of toxicological studies on a particular topic have searched, selected, and weighed the scientific evidence in a non-systematic and non-transparent way. Due to their narrative nature, these reviews tend to be subjective, potentially biased, and not readily reproducible. [1] Two examples highlighting these deficiencies are the risk assessments of trichloroethylene and bisphenol A (BPA). Twenty-seven different risk assessments of the evidence that trichloroethylene causes cancer have come to substantially different conclusions. [11] Assessments of BPA range from low risk of harm to the public to potential risks (for some populations), leading to different political decisions. [12] Systematic reviews can help reducing such divergent views. [3] In contrast with narrative reviews, they reflect a highly structured approach to reviewing and synthesizing the scientific literature while limiting bias. [3] The steps to carrying out a systematic review include framing the question to be addressed; identifying and retrieving relevant studies; determining if any retrieved studies should be excluded from the analysis; and appraising the included studies in terms of their methodological quality and risk of bias. Ultimately the data should be synthesized across studies, if possible by a meta-analysis. A protocol of how the review will be conducted is prepared ahead of time and ideally should be registered and/or published.

Scientists have made progress in their efforts to apply the systematic review framework to evaluating the evidence for associations between environmental toxicants and human health risks. To date, researchers have shown that important elements of the framework established in evidence-based medicine can be adapted to toxicology with little change, and some studies have been attempted. [13] [14] [15] Researchers using the systematic review methodology to address toxicological concerns include a group of scientists from government, industry, and academia in North America and the European Union (EU) who have joined together to promote evidence-based approaches to toxicology through the nonprofit Evidence-based Toxicology Collaboration (EBTC). The EBTC brings together the international toxicology community to develop EBT methodology and facilitate the use of EBT to inform regulatory, environmental and public health. [3] [16] [17]

Background

Evidence-based approaches were first conceived as a means of anchoring policy decisions, not to current practices or the beliefs of experts, but to experimental evidence. [18] Evidence-based medicine (EBM) was launched slightly later. Its rise as a distinct discipline is generally credited to the work and advocacy of Scottish epidemiologist Archie Cochrane. [19] The Cochrane Collaboration named in his honor was launched at Oxford University in 1993 to promote evidence-based reviews of clinical medical literature. More recently, EBM expanded to encompass evidence-based health care (EBHC).

EBM/HC involves the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients taking patients' preferences into account. [20] Prior to EBM, medical decisions about diagnosis, prevention, treatment or harm were often made without a rigorous evaluation of the alternatives. Research in the 1970s and 1980s showed that different physicians regularly recommended different treatments and tests for patients with ailments that were essentially the same, and that large proportions of procedures being performed by physicians were considered inappropriate by the standards of medical experts. [21] [22] EBM/HC supporters stress that while evidence always has been important to the practice of medicine, EBM/HC provides an enhanced approach of identifying, assessing, and summarizing evidence. EBT's supporters make a similar argument. [3]

The idea of translating evidence-based approaches from medicine to toxicology has been percolating for two decades, with proponents in both medicine and toxicology. [23] [24] Three research papers published in 2005 and 2006 catalyzed what eventually became known as EBT by suggesting that EBM's established tools and concepts might serve as a prototype of evidence-based decision-making in toxicology. [1] [9] [25]

Process and progress

The First International Forum Toward Evidence-Based Toxicology was held in 2007. [26] The forum was organized by the European Commission and attended by 170 scientists from more than 25 European, American, and Asian countries. The goal was to explore the available concepts of EBT, and to launch an initiative to formally implement evidence-based assessment methods in toxicology.

The starting point for the discussions were two research papers suggesting that the tools and concepts established in evidence-based medicine could serve as a prototype of evidence-based decision-making for evaluating toxicological data. [1] [9] Apparent fundamental differences between medicine and toxicology were carefully considered during these discussions. Forum participants attempted to bridge the two disciplines in order to make use of the accrued wisdom and apply this approach to toxicology. (See Archived 2017-07-29 at the Wayback Machine .)

The proceedings of this forum were published as a special issue in Human & Experimental Toxicology. [27]

EBT's proponents include experts in EBM, public health, and toxicology who believe that EBT can help toxicologists to better serve the goals of health protection and safety assurance. [15] [16] They argue that EBT's methodologies for collecting, appraising, and pooling evidence can help ensure that all available information on a given topic is evaluated in a transparent, unbiased, and reproducible manner. They contend that EBT's concept of the systematic review could prove particularly helpful for the standardization and quality assurance of novel methodologies for evaluating toxicity, as well as for their formal validation. In this regard, EBT may prove particularly useful for assessing the performance of newer non-animal "21st century" toxicology tools. EBT can also help scientists integrate new toxicological test methods into test strategies being implemented across the globe.

In 2010, a group of EBT supporters joined together to convene a workshop titled "21st Century Validation for 21st Century Tools". [28] The session on the potential for evidence-based approaches to assess the performance of the new generation of non-animal test methods inspired the formation of the EBTC. The EBTC was officially launched in the U.S. in 2011 at a Society of Toxicology conference [29] and convened its first workshop in 2012. [3] The EBTC's EU branch was officially opened during the 2012 Eurotox conference. [30]

In 2014, the EBTC hosted a workshop on "The Emergence of Systematic Review and Related Evidence-based Approaches in Toxicology" with speakers representing US and European organizations that are implementing and promoting the use of systematic reviews for toxicological questions. The experts noted that the structured approach of systematic reviews increases objectivity and transparency but also made clear that the approach requires a substantial time investment, which is a challenge to its more widespread adoption. Consequently, the participants called for close collaboration of interested organizations, which they determined to be a pre-requisite for the broad and efficient introduction of systematic reviews in toxicology. [29]

Applications of EBT

Regulatory decision-making

Some scientists and policymakers would like EBT to help them combine information from various sources. Toxicological evidence can be assigned to evidence streams, sets of studies representing the same type or level of evidence, such as human (observational) studies, animal studies, in vitro or mechanistic studies. EBT can be applied both within one evidence stream, and it is especially well-suited to be applied across multiple evidence streams. Regulators often designate one study as "the lead study", then use later studies as additional information. Many perceive this as unsatisfying, but objective approaches to combine study results are lacking. The EBM concept of the systematic review has promise for this application, and some structured reviews serve as forerunners for this approach. [31] [32] [33]

Evaluating effects of environmental exposures

The U.S. National Toxicology Program's Office of Health Assessment and Translation (OHAT) has started to use systematic review methodology for the program's evaluations. [34] The first systematic review was completed in 2016, reviewing the effects of fluoride on learning and memory in animal studies. [33] OHAT’s approach is tailored to its mandate, but its seems especially appropriate for substances with substantial yet conflicting literature, and hence the need for systematic reviews to sort out somewhat confusing situations.

Causation

One application of EBT focuses on causation. [25] It addresses the challenge of tracing a health effect back to a toxicant, such as lung cancer to smoking. This approach is similar to legal arguments [35] Some experts warn that this approach could increase the evidence burden for proving causation, and thereby increase the difficulty involved in banning toxic substances. [36]

Clinical toxicology

Practitioners of clinical toxicology, which is concerned with the treatment of patients known to be exposed to toxic substances, are also beginning to use an EBM-style approach. [37] [38] Guidance documents based on this approach have already been published

21st century toxicology

The National Research Council's (NRC) landmark 2007 publication, "Toxicity Testing in the 21st Century", has also been an impetus for EBT. EBT provides new tools for assessing test method performance. Also, as the focus of 21st-century toxicology shifts from animal biology to human biology, EBT provides a method for comparatively evaluating the results gleaned from new methods of investigating the effects of chemical exposure. [39]

The Evidence-based Toxicology Collaboration has pioneered a number of projects aimed at applying EBT approaches and systematic reviews to test methods comparison. [40] [41]

Limitations and challenges

The specific differences between toxicology and medicine/health care cause challenges for implementing EBT. [15] Evidence-based methodology of clinical research has been focused on a single type of study—randomized, controlled clinical trials, which are a direct measure of the effectiveness of the health care intervention under scrutiny. In contrast, toxicology employs a variety of different kinds of studies in three distinct evidence streams: human (observational) studies, animal studies, and non-animal studies. Because human evidence is frequently lacking most evidence is obtained by using animal and non-animal models, which—by definition—is more difficult to generalize and extrapolate to humans. This methodological heterogeneity complicates evidence integration within an evidence stream, such as when inconsistent evidence is obtained from different animal species, but even more so across evidence streams. Adding to the difficulty is the reality that much toxicological evidence, more so than in medicine and health care, is not readily accessible in the literature. [3] [15] Moreover, the role of expert judgment, especially in systematic reviews, needs to be clearly defined, as it is a common misperception that evidence-based approaches leave no room for it. Systematic reviews should strive to make expert judgments clear along with the scientific basis for those judgments in developing conclusions for a systematic review. Further issues to be worked out include exposures to multiple substances, the multitude of outcomes observed in some animal studies, and challenges in improving the experimental designs and reporting of studies.

See also

Related Research Articles

Evidence-based medicine (EBM) is "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. ... [It] means integrating individual clinical expertise with the best available external clinical evidence from systematic research." The aim of EBM is to integrate the experience of the clinician, the values of the patient, and the best available scientific information to guide decision-making about clinical management. The term was originally used to describe an approach to teaching the practice of medicine and improving decisions by individual physicians about individual patients.

<span class="mw-page-title-main">Toxicology</span> Study of substances harmful to living organisms

Toxicology is a scientific discipline, overlapping with biology, chemistry, pharmacology, and medicine, that involves the study of the adverse effects of chemical substances on living organisms and the practice of diagnosing and treating exposures to toxins and toxicants. The relationship between dose and its effects on the exposed organism is of high significance in toxicology. Factors that influence chemical toxicity include the dosage, duration of exposure, route of exposure, species, age, sex, and environment. Toxicologists are experts on poisons and poisoning. There is a movement for evidence-based toxicology as part of the larger movement towards evidence-based practices. Toxicology is currently contributing to the field of cancer research, since some toxins can be used as drugs for killing tumor cells. One prime example of this is ribosome-inactivating proteins, tested in the treatment of leukemia.

Polychlorinated dibenzodioxins (PCDDs), or simply dioxins, are a group of long-lived polyhalogenated organic compounds that are primarily anthropogenic, and contribute toxic, persistent organic pollution in the environment.

<span class="mw-page-title-main">Cochrane (organisation)</span> British nonprofit for reviews of medical research (formed 1993)

Cochrane is a British international charitable organisation formed to synthesize medical research findings to facilitate evidence-based choices about health interventions involving health professionals, patients and policy makers. It includes 53 review groups that are based at research institutions worldwide. Cochrane has over 37,000 volunteer experts from around the world.

Chlordane, or chlordan, is an organochlorine compound that was used as a pesticide. It is a white solid. In the United States, chlordane was used for termite-treatment of approximately 30 million homes until it was banned in 1988. Chlordane was banned 10 years earlier for food crops like corn and citrus, and on lawns and domestic gardens.

<span class="mw-page-title-main">Chelation therapy</span> Medical procedure to remove heavy metals from the body

Chelation therapy is a medical procedure that involves the administration of chelating agents to remove heavy metals from the body. Chelation therapy has a long history of use in clinical toxicology and remains in use for some very specific medical treatments, although it is administered under very careful medical supervision due to various inherent risks, including the mobilization of mercury and other metals through the brain and other parts of the body by the use of weak chelating agents that unbind with metals before elimination, exacerbating existing damage. To avoid mobilization, some practitioners of chelation use strong chelators, such as selenium, taken at low doses over a long period of time.

<span class="mw-page-title-main">Perfluorooctanoic acid</span> Perfluorinated carboxylic acid

Perfluorooctanoic acid is a perfluorinated carboxylic acid produced and used worldwide as an industrial surfactant in chemical processes and as a material feedstock. PFOA is considered a surfactant, or fluorosurfactant, due to its chemical structure, which consists of a perfluorinated, n-heptyl "tail group" and a carboxylic acid "head group". The head group can be described as hydrophilic while the fluorocarbon tail is both hydrophobic and lipophobic.

<span class="mw-page-title-main">Endocrine disruptor</span> Chemicals that can interfere with endocrine or hormonal systems

Endocrine disruptors, sometimes also referred to as hormonally active agents, endocrine disrupting chemicals, or endocrine disrupting compounds are chemicals that can interfere with endocrine systems. These disruptions can cause numerous adverse human health outcomes, including alterations in sperm quality and fertility; abnormalities in sex organs‚ endometriosis‚ early puberty‚ altered nervous system or immune function; certain cancers; respiratory problems; metabolic issues; diabetes, obesity, or cardiovascular problems; growth, neurological and learning disabilities, and more. Found in many household and industrial products, endocrine disruptors "interfere with the synthesis, secretion, transport, binding, action, or elimination of natural hormones in the body that are responsible for development, behavior, fertility, and maintenance of homeostasis ."

Toxicogenomics is a subdiscipline of pharmacology that deals with the collection, interpretation, and storage of information about gene and protein activity within a particular cell or tissue of an organism in response to exposure to toxic substances. Toxicogenomics combines toxicology with genomics or other high-throughput molecular profiling technologies such as transcriptomics, proteomics and metabolomics. Toxicogenomics endeavors to elucidate the molecular mechanisms evolved in the expression of toxicity, and to derive molecular expression patterns that predict toxicity or the genetic susceptibility to it.

<span class="mw-page-title-main">Systematic review</span> Comprehensive review of research literature using systematic methods

A systematic review is a scholarly synthesis of the evidence on a clearly presented topic using critical methods to identify, define and assess research on the topic. A systematic review extracts and interprets data from published studies on the topic, then analyzes, describes, critically appraises and summarizes interpretations into a refined evidence-based conclusion. For example, a systematic review of randomized controlled trials is a way of summarizing and implementing evidence-based medicine. Systematic reviews, sometimes along with meta-analyses, are generally considered the highest level of evidence in medical research.

A hierarchy of evidence, comprising levels of evidence (LOEs), that is, evidence levels (ELs), is a heuristic used to rank the relative strength of results obtained from experimental research, especially medical research. There is broad agreement on the relative strength of large-scale, epidemiological studies. More than 80 different hierarchies have been proposed for assessing medical evidence. The design of the study and the endpoints measured affect the strength of the evidence. In clinical research, the best evidence for treatment efficacy is mainly from meta-analyses of randomized controlled trials (RCTs). Systematic reviews of completed, high-quality randomized controlled trials – such as those published by the Cochrane Collaboration – rank the same as systematic review of completed high-quality observational studies in regard to the study of side effects. Evidence hierarchies are often applied in evidence-based practices and are integral to evidence-based medicine (EBM).

<span class="mw-page-title-main">Homosalate</span> Chemical compound

Homosalate is an organic compound used in some sunscreens. It is made by the Fischer–Speier esterification of salicylic acid and 3,3,5-trimethylcyclohexanol, the latter being a hydrogenated derivative of isophorone. Contained in 45% of U.S. sunscreens, it is used as a chemical UV filter. The salicylic acid portion of the molecule absorbs ultraviolet rays with a wavelength from 295 nm to 315 nm, protecting the skin from sun damage. The hydrophobic trimethyl cyclohexyl group provides greasiness that prevents it from dissolving in water.

Nanotoxicology is the study of the toxicity of nanomaterials. Because of quantum size effects and large surface area to volume ratio, nanomaterials have unique properties compared with their larger counterparts that affect their toxicity. Of the possible hazards, inhalation exposure appears to present the most concern, with animal studies showing pulmonary effects such as inflammation, fibrosis, and carcinogenicity for some nanomaterials. Skin contact and ingestion exposure are also a concern.

<span class="mw-page-title-main">2,3,7,8-Tetrachlorodibenzodioxin</span> Polychlorinated dibenzo-p-dioxin, chemical compound

2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD) is a polychlorinated dibenzo-p-dioxin (sometimes shortened, though inaccurately, to simply 'dioxin') with the chemical formula C12H4Cl4O2. Pure TCDD is a colorless solid with no distinguishable odor at room temperature. It is usually formed as an unwanted product in burning processes of organic materials or as a side product in organic synthesis.

Evidence-based dentistry (EBD) is the dental part of the more general movement toward evidence-based medicine and other evidence-based practices. The pervasive access to information on the internet includes different aspects of dentistry for both the dentists and patients. This has created a need to ensure that evidence referenced to are valid, reliable and of good quality.

The Klimisch score is a method of assessing the reliability of toxicological studies, mainly for regulatory purposes, that was proposed by H.J. Klimisch, M. Andreae and U. Tillmann of the chemical company BASF in 1997 in a paper entitled A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data which was published in Regulatory Toxicology and Pharmacology. It assigns studies to one of four categories as follows:

The non-profit Evidence-based Toxicology Collaboration (EBTC) comprises a group of scientists and experts with ties to governmental and non-governmental agencies, chemical and pharmaceutical companies, and academia that have banded together to promote the use of what are known as "evidence-based approaches" in toxicology. The discipline of evidence-based toxicology (EBT) is a process for transparently, consistently, and objectively assessing available scientific evidence in order to answer questions in toxicology. EBT has the potential to address concerns in the toxicological community about the limitations of current approaches. These include concerns related to transparency in decision making, synthesis of different types of evidence, and the assessment of bias and credibility. The evidence-based methods and approaches now being proposed for toxicology are widely used in medicine, which is the basis for their nomenclature. The need to improve how the performance of toxicological test methods is assessed was the main impetus for translating these tools to toxicology.

eTOX Toxicology data consortium

eTOX is a temporary consortium established in 2010 to share and use toxicology data. It is a pre-competitive collaboration which main goal is to create and distribute tools to predict drug side-effects based on pre-clinical experiments. Aims are a better in silico predictability of potential adverse events and a decrease of the use of animals in toxicological research. eTOX is funded by the Innovative Medicines Initiative (IMI).

The Centre for Evidence-Based Medicine (CEBM), based in the Nuffield Department of Primary Care Health Sciences at the University of Oxford, is an academic-led centre dedicated to the practice, teaching, and dissemination of high quality evidence-based medicine to improve healthcare in everyday clinical practice. CEBM was founded by David Sackett in 1995. It was subsequently directed by Brian Haynes and Paul Glasziou. Since 2010 it has been led by Professor Carl Heneghan, a clinical epidemiologist and general practitioner.

<span class="mw-page-title-main">Toxicology of carbon nanomaterials</span> Overview of toxicology of carbon nanomaterials

Toxicology of carbon nanomaterials is the study of toxicity in carbon nanomaterials like fullerenes and carbon nanotubes.

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