Software Tools for Model-Informed Precision Dosing: How Well Do They Satisfy the Needs?

Abstract

Model-informed precision dosing (MIPD) software tools are used to optimize dosage regimens in individual patients, aiming to achieve drug exposure targets associated with desirable clinical outcomes. Over the last few decades, numerous MIPD software tools have been developed. However, they have still not been widely integrated into clinical practice. This study focuses on identifying the requirements for and evaluating the performance of the currently available MIPD software tools. First, a total of 22 experts in the field of precision dosing completed a web survey to assess the importance (from 0; do not agree at all, to 10; completely agree) of 103 pre-established software tool criteria organized in eight categories: user-friendliness and utilization, user support, computational aspects, population models, quality and validation, output generation, privacy and data security, and cost. Category mean ± pooled standard deviation importance scores ranged from 7.2 ± 2.1 (user-friendliness and utilization) to 8.5 ± 1.8 (privacy and data security). The relative importance score of each criterion within a category was used as a weighting factor in the subsequent evaluation of the software tools. Ten software tools were identified through literature and internet searches: four software tools were provided by companies (DoseMeRx, InsightRX Nova, MwPharm++, and PrecisePK) and six were provided by non-company owners (AutoKinetics, BestDose, ID-ODS, NextDose, TDMx, and Tucuxi). All software tools performed well in all categories, although there were differences in terms of in-built software features, user interface design, the number of drug modules and populations, user support, quality control, and cost. Therefore, the choice for a certain software tool should be made based on these differences and personal preferences. However, there are still improvements to be made in terms of electronic health record integration, standardization of software and model validation strategies, and prospective evidence for the software tools' clinical and cost benefits.

Keywords: model-informed precision dosing; pharmacometrics; software tool; target concentration intervention; therapeutic drug monitoring.

Figure 1

Flowchart of the included and excluded model-informed precision dosing software tools. GUI, graphical user interface.

Figure 2

Overview of drug classes involved in precision dosing programs of the participating experts.

Figure 3

The overall mean (±1 pooled standard deviation; dashed lines) of importance levels of the considered criteria in the eight categories.

Figure 4

Tukey boxplot representing fulfillment of the considered criteria by the 10 evaluated software tools in each category.

Figure 5

Fulfillment of the considered criteria in the eight categories by each of the evaluated software tools. Numbers in parentheses are percentage of the overall performance scores. Software tools are ranked in decreasing order of overall performance scores [from the highest score (A) to the lowest score (J)]. Black solid circles in each category represent the median fulfillment (%) of the considered criteria by the 10 evaluated software tools. ^*Manual data entry not possible. ^†A report cannot be generated. ^‡The data privacy method in data collection cannot be evaluated since no data are collected in the software. ^§Database encoding cannot be evaluated since no data are stored in the software. ^|An individual license is not available. ^¶An institution license is not available.