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A Framework that Considers the Impacts of Time, Cost, and Uncertainty in the Determination of the Cost Effectiveness of Toxicity-Testing Methodologies
Citation:
Price, P., B. Hubbell, S. Hagiwara, G. Paoli, D. Krewski, A. Guiseppi-Elie, M. Gwinn, N. Adkins, AND R. Thomas. A Framework that Considers the Impacts of Time, Cost, and Uncertainty in the Determination of the Cost Effectiveness of Toxicity-Testing Methodologies. RISK ANALYSIS. Blackwell Publishing, Malden, MA, 42(4):707-729, (2022). https://doi.org/10.1111/risa.13810
Impact/Purpose:
The resource intensive nature of traditional toxicological testing – including both time and cost – and the lack of data for many chemicals has spawned a number of initiatives to improve toxicity testing by increasing speed, reducing costs, and improving efficiency. Many of these efforts have focused on replacing traditional in vivo test systems with a range of in silico, in vitro, and in chemico methods, along with integrated approaches to testing and assessment. These efforts will result in regulatory agencies having a choice of different test methods needed for evaluating the potential for health and environmental risks of untested chemicals. The selection of the most appropriate testing methodology requires balancing differences in the cost and the duration of testing and the uncertainty in the resulting findings across the suite of methodologies under consideration. Cost effectiveness analysis (CEA) is a decision-support tool that systematically evaluates different courses of action to determine the best option to achieve a specified desirable outcome at the lowest cost. CEA provides a natural basis for identifying the least expensive approach to achieve a specified outcome. CEA is a well-established approach for designing therapeutic strategies and health care budget resource allocation. CEA has also been applied to the use of different toxicity-testing methodologies. This article presents a framework for performing CEAs to select the most appropriate toxicity-testing methodology for evaluating the large numbers of chemicals in commerce that currently have little or no toxicity data.
Description:
Regulatory agencies are required to evaluate the impacts of thousands of chemicals. Toxicological tests currently used in such evaluations are time-consuming and resource intensive; however, advances in toxicology and related fields are providing new testing methodologies that reduce the cost and time required for testing. The selection of a preferred methodology is challenging because the new methodologies vary in duration and cost, and the data they generate vary in the level of uncertainty. This article presents a framework for performing cost-effectiveness analyses (CEAs) of toxicity tests that account for cost, duration, and uncertainty. This is achieved by using an output metric-the cost per correct regulatory decision-that reflects the three elements. The framework is demonstrated in two example CEAs, one for a simple decision of risk acceptability and a second, more complex decision, involving the selection of regulatory actions. Each example CEA evaluates five hypothetical toxicity-testing methodologies which differ with respect to cost, time, and uncertainty. The results of the examples indicate that either a fivefold reduction in cost or duration can be a larger driver of the selection of an optimal toxicity-testing methodology than a fivefold reduction in uncertainty. Uncertainty becomes of similar importance to cost and duration when decisionmakers are required to make more complex decisions that require the determination of small differences in risk predictions. The framework presented in this article may provide a useful basis for the identification of cost-effective methods for toxicity testing of large numbers of chemicals.
URLs/Downloads:
DOI: A Framework that Considers the Impacts of Time, Cost, and Uncertainty in the Determination of the Cost Effectiveness of Toxicity-Testing Methodologies
https://pubmed.ncbi.nlm.nih.gov/34490933/