Metabolomics in Early-Phase Clinical Trials from 2010 to 2025
- 1William Harvey Research Institute, Queen Mary University of London, London EC1M 6BQ, UK
- 2Department of HIV Medicine, Chelsea and Westminster Hospital, London SW10 9NH, UK
- 3Department of Infectious Disease, Imperial College London, London SW7 2AZ, UK
Abstract
Background/Objectives: Metabolomics has the potential to enhance the definition of medication response phenotypes in early-phase clinical trials, yet global uptake and distribution are not well characterised. This study provides an international assessment of metabolomics integration in registered early-phase clinical trials. Methods: Data were obtained from the World Health Organization’s International Clinical Trials Registry Platform (ICTRP). Early-phase trials (phase 0–II) conducted from 2010 to 2025 were analysed, and metabolomics studies were identified using predefined keyword searches across trial records. Results: A total of 183,041 early-phase trials were identified, of which 640 (0.35%) incorporated metabolomics. Uptake has increased modestly over time but remains low overall and is concentrated predominantly in high-income countries. The United Kingdom demonstrated the highest proportional integration (1.3%), while the People’s Republic of China (n = 237) and the United States of America (n = 90) contributed the greatest absolute number of trials with metabolomics. Among the included metabolomic studies: 187 (29.2%) were phase 0, 229 (35.8%) were phase I trials, 183 (28.6%) were phase II, and 41 (6.4%) were combined phase I/II studies. Metabolomics was most commonly included as a secondary, rather than primary outcome (49.7% vs. 25.3%). Conclusions: Metabolomics remains underutilised in early-phase clinical trials. Addressing barriers to implementation will be critical to enable broader integration of metabolomics into early-phase clinical trials and to integrate a multi-omic approach to precision medicine.
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BibTeX
@article{thompson2026metabolomics,
title = {{Metabolomics in Early-Phase Clinical Trials from 2010 to 2025}},
author = {Jack T. Thompson and Maia Megase and Marta Boffito and Mark J. Caulfield and Emma F. Magavern},
journal = {Metabolites},
year = {2026},
month = oct,
doi = {10.3390/metabo16100777},
url = {https://www.mdpi.com/2218-1989/16/10/777},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Metabolomics in Early-Phase Clinical Trials from 2010 to 2025
AU - Jack T. Thompson
AU - Maia Megase
AU - Marta Boffito
AU - Mark J. Caulfield
AU - Emma F. Magavern
PY - 2026
DA - 2026/10/01
JO - Metabolites
DO - 10.3390/metabo16100777
UR - https://www.mdpi.com/2218-1989/16/10/777
AB - Background/Objectives: Metabolomics has the potential to enhance the definition of medication response phenotypes in early-phase clinical trials, yet global uptake and distribution are not well characterised. This study provides an international assessment of metabolomics integration in registered early-phase clinical trials. Methods: Data were obtained from the World Health Organization’s International Clinical Trials Registry Platform (ICTRP). Early-phase trials (phase 0–II) conducted from 2010 to 2025 were analysed, and metabolomics studies were identified using predefined keyword searches across trial records. Results: A total of 183,041 early-phase trials were identified, of which 640 (0.35%) incorporated metabolomics. Uptake has increased modestly over time but remains low overall and is concentrated predominantly in high-income countries. The United Kingdom demonstrated the highest proportional integration (1.3%), while the People’s Republic of China (n = 237) and the United States of America (n = 90) contributed the greatest absolute number of trials with metabolomics. Among the included metabolomic studies: 187 (29.2%) were phase 0, 229 (35.8%) were phase I trials, 183 (28.6%) were phase II, and 41 (6.4%) were combined phase I/II studies. Metabolomics was most commonly included as a secondary, rather than primary outcome (49.7% vs. 25.3%). Conclusions: Metabolomics remains underutilised in early-phase clinical trials. Addressing barriers to implementation will be critical to enable broader integration of metabolomics into early-phase clinical trials and to integrate a multi-omic approach to precision medicine.
SN - 2218-1989
ER -