Table 4 Current challenges and potential approaches to biomarker development in critical care nutrition
Challenges | Solutions |
|---|---|
Understand biological mechanisms | Multidisciplinary consortia with basic, translational, and clinical scientists focused on pre-clinical and clinical mechanistic models of nutrition and metabolism. |
Characterize metabolic heterogeneity and response to nutrition support with respect to: • Kinetics • Nutrition support modality • Dose | Longitudinal cohorts and/or phase I or II clinical trials with the collection of granular physiological and omics data that can be correlated with meaningful clinical endpoints. Emphasis is placed on genomic, transcriptomic, epigenomic, and microbiome patterns of metabolic response to nutrition support. |
Identify diagnostic and prognostic biomarkers that can classify responses to nutrition support by: • Likelihood of response • Appropriate timing of initiation • Adequacy of modality and dose | The statistical reduction of multidimensional data sets collected over time into biomarker panels that can capture endotype-driven treatment effects and population heterogeneity, thereby permitting the design of “smart” trials. |
Validate and implement biomarkers | Leverage detailed observational cohorts or multi-center RCT’s establish external validity, utility, and feasibility in large multi-center RCTs. |
Foster the development of biomarker in critical care nutrition research and program development | Promote biomarker development in the early stages of pre-clinical and clinical study design and the adoption of biomarkers for risk stratification tools in clinical trials. |
Overcome technological and economic barriers: • Assay complexity • Sampling • Cost | Focus on samples that can be easily obtained at low cost (e.g., blood) and assays that can be feasibly adopted as point-of-care tests (e.g., PCR, ELISA). |