Abstract

Background:

Some 20 y ago, scientific and regulatory communities identified the potential of omics sciences (genomics, transcriptomics, proteomics, metabolomics) to improve chemical risk assessment through development of toxicogenomics. Recognizing that regulators adopt new scientific methods cautiously given accountability to diverse stakeholders, the scope and pace of adoption of toxicogenomics tools and data have nonetheless not met the ambitious, early expectations of omics proponents.

Objective:

Our objective was, therefore, to inventory, investigate, and derive insights into drivers of and obstacles to adoption of toxicogenomics in chemical risk assessment. By invoking established social science frameworks conceptualizing innovation adoption, we also aimed to develop recommendations for proponents of toxicogenomics and other new approach methodologies (NAMs).

Methods:

We report findings from an analysis of 56 scientific and regulatory publications from 1998 through 2017 that address the adoption of toxicogenomics for chemical risk assessment. From this purposeful sample of toxicogenomics discourse, we identified major categories of drivers of and obstacles to adoption of toxicogenomics tools and data sets. We then mapped these categories onto social science frameworks for conceptualizing innovation adoption to generate actionable insights for proponents of toxicogenomics.

Discussion:

We identify the most salient drivers and obstacles. From 1998 through 2017, adoption of toxicogenomics was understood to be helped by drivers such as those we labeled Superior scientific understanding, New applications, and Reduced cost & increased efficiency but hindered by obstacles such as those we labeled Insufficient validation, Complexity of interpretation, and Lack of standardization. Leveraging social science frameworks, we find that arguments for adoption that draw on the most salient drivers, which emphasize superior and novel functionality of omics as rationales, overlook potential adopters’ key concerns: simplicity of use and compatibility with existing practices. We also identify two perspectives—innovation-centric and adopter-centric—on omics adoption and explain how overreliance on the former may be undermining efforts to promote toxicogenomics. https://doi.org/10.1289/EHP6500

中文翻译：

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采用毒物基因组学进行化学风险评估的驱动因素和障碍：社会科学视角的见解

摘要

背景：

大约20年前，科学和监管机构已经确定了组学科学（基因组学，转录组学，蛋白质组学，代谢组学）通过开发毒理基因组学改善化学风险评估的潜力。认识到监管机构谨慎地采用新的科学方法，要对不同的利益相关者负责，因此，采用毒理基因组学工具和数据的范围和速度仍未达到组学拥护者的雄心勃勃的早期期望。

目的：

因此，我们的目标是清点，调查并深入了解在化学风险评估中采用毒理基因组学的驱动因素和障碍。通过调用概念化创新采用的已建立的社会科学框架，我们还旨在为毒物基因组学和其他新方法方法论（NAM）的支持者提出建议。

方法：

我们报告了1998年至2017年间对56种科学和法规出版物的分析结果，这些出版物涉及采用毒理基因组学进行化学风险评估。从毒理基因组学研究的目的样本中，我们确定了毒理基因组学工具和数据集采用的主要驱动因素和障碍。然后，我们将这些类别映射到社会科学框架上，以概念化创新的采用，从而为毒理基因组学的支持者提供可行的见解。

讨论：

我们确定最明显的驱动因素和障碍。从1998年到2017年，毒理基因组学的采用被认为是受驱动因素帮助的，例如我们将其标记为``卓越科学理解''，``新应用''，``降低成本和提高效率''，但受到诸如``验证不足，解释的复杂性和缺乏标准化。利用社会科学框架，我们发现采用最突出的推动因素的采用论据，将组学的优越性和新颖性作为基本原理，而忽视了潜在采用者的关键问题：使用简单和与现有实践的兼容性。我们还确定了以组学为中心的以创新为中心和以采用者为中心的两种观点，并解释了对前者的过度依赖可能会破坏促进毒理基因组学的努力。https://doi.org/10.1289/EHP6500